At Flowonix, our patient centric approach drives the design, development, and deployment of targeted drug delivery platforms whose sole purpose is to provide physicians an optimal solution for the treatment of their patients' numerous neurological disorders.
- Character – The common thread of our culture. One is never wrong doing what is right.
- Integrity – Saying exactly what we mean and doing what we say.
- Relentless – While never at the expense of progress, we push for perfection.
- Purpose – Optimizing patient outcomes is our greater cause.
It's the desire to help people with life-changing technology that drives every member of the Flowonix team. At Flowonix we believe our employees are an essential component to our long-term success, and it is this mindset that drives our commitment to offer unique career opportunities.
We are passionate about having a diverse and talented workforce to solve the big problems we are seeking to tackle. We offer a competitive health and benefits package.
Browse our current job openings below. If you do not see any current openings but are interested in joining our team, please feel free to send an email to firstname.lastname@example.org
Position Location: Throughout the U.S.
Accountability Objective: Territory Manager (Sales Representative) is responsible for achieving sales of Flowonix Medical's medical devices IN accordance with Company plans and providing a positive depiction of Flowonix within the medical community.
- Sell Flowonix Medical's products to achieve Company sales objectives. Calls on clients, makes presentations, perform set-ups and demonstrations. Prepares proposals. Responds to customer and potential customer inquiries. Provides product and pricing information.
- Develops and maintains effective relationships with existing and potential clients. Responds well to customer needs, by understanding customer requirements and striving for complete customer satisfaction.
- Follows-up on leads from tradeshow and other marketing activities. Reports regularly on lead generation activity and results of lead follow-up.
- Participates in trade show activities including set-up, product demonstrations and displays, distribution of marketing materials, presentations in Company symposiums and client-related activities.
- Supports new product releases. Implements the initial stages of the launch of new products and/or new technologies with training programs and materials, ads, attendance and demonstrations at identified major meetings, case studies, Journal reviews, and sales updates.
- Exhibits strong work/organizational habits as they relate to planning and time and territory management skills. Prioritizes activities effectively. Manages effective expense control.
- Demonstrates a "team" attitude. Interacts with others within the organization. Displays a willingness to assist others in the field. Handles conflict in a positive manner, while striving for a win-win solution.
- Understands that the selling process includes developing and implementing strategies for securing payment for purchased products.
- Assists in the development of forecasts for all products and in the development and management of budgets in support of sales and marketing plans.
- Territory management and analysis of sales trends, utilization of appropriate business partners to present marketing and business plans to accounts for territory development and growth.
Knowledge/Educational Requirements: Bachelor's Degree in Science/Business or equivalent; strong preference for two years minimum referral/therapy development sales experience; successful three to five years total medical experience to surgeons, administrative staff, and payers. Solid knowledge of the Reimbursement climate; experience call on physicians in one or more of the following or related referral accounts - Psychiatrist, Oncology, Internal Medicine, or Primary Care Physician/GP; experience in developing new, innovative markets; experience in making multiple referral calls on a daily basis; familiarity with the OR is a plus.
Skills and Abilities: Solid job skills in business planning/consulting and territory financial analysis; preferred knowledge of managed care, physiology/clinical therapies, and implantable devices; excellent interpersonal, communication, negotiation skills; team oriented; conceptual/consultative sales skills. Ability to successfully operate in a team environment and be an "out of the box" thinker to address unique problems.
Physical Demands/Work Environment: Lifting/carrying 20 pounds; sit/stand/walk 6-8 hours a day; operate a moving vehicle; Environment Exposures; eye protection, infectious disease, and radiation.
Internal Contacts: Marketing, Regulatory, Clinical Field Engineering, and Management.
External Contacts: Physicians, clinical staff, Key Opinion Leaders, purchasing, OR staff and management, Hospital/ASC pain referral community, coding/billing representatives from similar pain markets/co-promote opportunities, physician office managers and marketing representatives.
Position Location: Mansfield, MA
Accountability Objective: Responsible for the completion of assigned US and OUS Regulatory Submission and Compliance activities of Flowonix Medical and its designated suppliers; coordinate assigned US and OUS regulatory reporting, such as MDRs, Vigilance Reports, Clinical Progress Reports, and Post-Approval Reports; provide support for: US and OUS regulatory submissions of new and existing products marketed by Flowonix Medical; assure compliance with US and OUS international regulatory requirements for Class III (US) and Active Implantable Medical Devices (EU).
- Responsible for preparation of US regulatory submissions for new product and submissions related to maintenance of current Flowonix product line.
- Responsible for the preparation of OUS regulatory submissions and registrations in order to maintain the design dossier and compliance to the essential requirements and essential principles.
- Participate in cross-functional product development teams on behalf of Regulatory Affairs and Flowonix Medical. Identify and help resolve product development issues which relate to regulatory submission activities. Coach technical activities to achieve compliance with essential requirements (e.g., design control, design validation).
- Maintain current knowledge of FDA and international regulations, guidance and standards applicable to company products.
- Responsible for supporting ongoing manufacturing related to regulatory affairs, such as reviewing nonconforming material reports, engineering change notices, verification and validation protocols and reports, corrective and preventative actions and ensuring compliance with regulatory approvals and internal procedures.
- Responsible for ensuring compliance with reporting requirements related to US and OUS approvals such as MDRs, Vigilance Reporting, Post Approval Study Reports, Progress Reports and reports related to IDE approvals.
- Support regulatory involvement in the overall compliance program to meet the medical device requirements of FDA and international agencies pertaining to marketing, manufacturing, quality, clinical and product surveillance.
- Participate in overall document management strategies which support the device history file required by FDA regulations and product design dossier required OUS for obtaining a design examination certificate. Support ongoing activities within other departments; carry out departmental administrative duties and management staff duties.
- Provide guidance for internal staff on regulatory matters
- Assigned tasks related to US and OUS regulatory submissions to support product approvals
Minimum of Bachelors-level degree with 4 years experience in medical device; experience with complaint investigation and MDR/Vigilance reporting; excellent working knowledge of US (QSR) and OUS Quality System requirements (ISO-13485:2016) and requirements to obtain and maintain US Class III and EU Active Implantable medical device marketing approvals. Experience with software containing electronic medical devices.
Must be able to effectively and persuasively communicate in English language, both verbally and in writing; must be able to read and understand scientific literature and clinical articles.
Proficient with Microsoft Office Suite of software applications, especially Word, Excel, PowerPoint and Outlook; electronic submissions require expert knowledge of Adobe Acrobat 8.0 or later. Working knowledge of Microsoft Visio, Adobe Photoshop, and other document creation tools (e.g., scanning) desirable. Must be able to conduct effective research using web-based search tools and databases.
Technical/Problem Solving Skills:
Organized with excellent technical, analytical and problem-solving abilities; strong interpersonal skills; project management and team participation skills required.
Physical Demands/Work Environment:
Office environment, heavy PC usage; travel required up to 10% (domestic and international).
- Internal Contacts: Heavy cross-functional contact with all departments.
- External Contacts: Consultants and suppliers.
Position Location: Mt. Olive, NJ
Accountability Objective: The Director, Product Surveillance will provide strategic and tactical direction regarding post-market product surveillance, and utilization of clinical information. Post-market product surveillance includes reactive surveillance generated from products used in the field (complaints), as well as proactive surveillance generated from information in the scientific literature and information obtained from manufacturing and quality system activities, including CAPA and risk management activities. Medical Affairs includes review, approval and dissemination of medical and technical product information, as well as functions related to Safety Officer responsibilities.
- Provide strategic leadership and supervision of the Product Surveillance team in the execution of timely, high quality and consistent product complaints management, including appropriate identification and response to risks, adverse event reporting decisions, and collection and documentation of complaints (the scope of responsibility includes leadership for directing all Post Market Surveillance activities)
- Supervise, monitor, and engage Product Surveillance staff, while also managing the organizational structure and staffing for the Product Surveillance Team to ensure the management of product complaints is executed according to regulatory requirements and customer expectations
- Harmonize the complaint handling process, ensure regulatory compliance, and drive continuous improvement within the Product surveillance teams
- Establish and maintain strong relationships to enforce customer feedback investigations and to ensure that adequate corrective actions are being implemented in a timely manner, acting appropriately when things need to be escalated for senior management involvement
- Lead interactions with other functions as required with respect to customer feedback investigation, assessing appropriateness of investigations and corrective actions
- Lead the monitoring of the customer feedback and safety profile of products, including signal detection, and management of signal evaluation activities and documentation
- Use risk management skills to analyze adverse event information and determine if further adverse health outcome details are required for reportability decision-making, and determine if events are reportable to regulators
- Manage the preparation of aggregate customer feedback reports, and consequent review of Risk Management Plans, relevant sections of regulatory documents and health authority responses
- Provide scientific input into evaluation of customer feedback
- Provide scientific input into safety documents and relevant sections of regulatory documents such as safety analyses, expert statements, submission dossiers, health authority responses, clinical study reports and protocols
- Oversee development of safety data reviews for Clinical Evaluation Reports, Annual Reports and Health Hazard Assessments
- Study Management Team Member
- Review and author safety sections of the investigators’ brochure (IB), protocols, clinical safety reports (CSRs), informed consent forms (ICFs), and safety narratives for sponsored clinical trials and/or investigator sponsored trials (ISTs)
- Contribute to the development of the safety information section in the IB
- Contribute to safety analyses in Regulatory Submissions
- Provide clinical and scientific information to customers, including management of journal articles related to Flowonix products
- Direct activities and requirements related to Patient Device Tracking Database system
- Establish a system in compliance with regulatory requirements for dissemination of off-label scientific material to health care professionals
Decision-Making Authority: Drives execution of corporate strategies and objective regarding matters pertaining to achievement of established plans and conformance to appropriate FDA requirements.
- Bachelor’s Degree in an Engineering, Science or related discipline
- Advanced clinically oriented degree: PharmD., Ph.D., Nurse Practitioner or M.D.
- Minimum of ten (10) years of experience with Post Market Surveillance /Customer Complaints concepts, principles and systems
- Minimum of five (5) years of experience in the medical device industry, preferably with PMA devices
- Knowledge of FDA Quality System Regulations (21 CFR Part 820) and ISO13485.
- Working knowledge of product risk management for both pre-market development activities and post market safety surveillance activities
- Previous experience in scientific/medical writing is desired
Skills and Abilities:
- Bachelor’s Degree in an Engineering, Science or related discipline. Demonstrated ability to organize, prioritize and manage safety compliance deliverables with a focus on patient safety and regulatory compliance
- Ability to read and analyze scientific and medical literature
- Experience building, growing and developing a Product Surveillance team
- Ability to lead and manage at all levels of the organization.
- Strong analytical skills and attention to detail
- Strong project management and strategic planning skills
- Excellent interpersonal and communication skills, including proven verbal, written, and presentation skills
Physical Demand/Work Environment:
Normal office environment
1. Internal Contacts: All Departments
2. External Contacts: All aspects of US Customers
Position Location: Mt. Olive, NJ
Accountability Objective: Under the general direction of the Sr. VP, Clinical, Quality, and Regulatory Affairs, the Director of Clinical Affairs is responsible for the execution and management of clinical studies that support Research, Development and Marketing objectives for medical devices serving the Company’s markets. This position will develop effective clinical studies and manage trials in compliance with applicable regulations and policies.
- Support clinical studies activities with regard to protocol development, data collection, data analysis and reporting requirements, to include but not limited to: US FDA IDE/IDE Supplements, Progress Reports, and other required reports (e.g., site enrollment); European Union notified body clinical study interim and final reports in support of CE mark activities; adverse event reporting to regulatory bodies, as appropriate; local Ethics Committee and Institutional Review Board (IRB) submissions as they relate to regulatory requirements during the course of clinical trials.
- Work with Marketing and Sales Department to develop post marketing studies to support marketing strategies and develop data to support peer review articles and presentations for neuromodulation meetings.
- Point of contact for development of abstracts, posters and other publications
- Determines study objectives, strategy, scope and schedule in order to meet business needs.
- Develop study materials, including investigator’s brochures, regulatory binders, and case report forms.
- Oversees data management activities (e.g. creation of CRFs, CRF completion guides, data management plan, monitoring plan, actual monitoring data validation).
- Interfaces with statisticians regarding analysis plans, report tables, audits and logic checks.
- Oversees maintenance of all clinical (site) files.
- Interfaces with central IRB(s).
- Creates clinical SOPs and guidelines as necessary, and is responsible for ensuring compliance.
- Selects, interfaces with, and assures training of investigators and clinical staff.
- Ensure adequate monitoring is conducted on all clinical trials.
- Enlists support and specifies tasks for various clinical team members to assure meeting study objectives/schedule.
- Communicates study progress site and company personnel on a regular basis.
- Evaluates clinical data/information, providing interim and final reports, convening and directing investigator conferences to review findings and provide advice on direction.
- Provides input and support for planning post-clinical activities and market launch of products.
- Develops and manages budgets for assigned studies, including allocating payments to sites for CRF completion and for study activities/procedures (if applicable).
- Controls device distribution and allocation.
- All other duties and responsibilities as assigned.
- Provide guidance to internal/external staff and contract research organization regarding compliance issues with clinical protocols, ICH/GCP guidelines, safety guidelines and reimbursement regulations.
- Approve clinical sites to receive investigational product.
- Perform review and assignment of reported SAE’s to medical adviser.
- Respond to BIMO audit observations/queries.
- Recommend to Sr. VP, Clinical, Quality, and Regulatory Affairs response to FDA audit observations.
Bachelor’s Degree in engineering, biomedical sciences or related medical/scientific field. Advanced Degree preferred. Minimum 5 years experience directly supporting clinical research, biological or similar experiences in a technical/scientific area. Experience in implantable medical device applications.
Skills and Abilities
- Thorough knowledge of clinical trial process from start-up to close out.
- Development of clinical trials in compliance with ICH/GCP guidelines including authoring and managing relevant clinical SOP’s.
- Strong interpersonal, communication, writing, and organizational skills required to effectively work in clinical and project team environment.
- Strong leadership and management of cross functional team including trial/data managers, field personnel, consultants and vendors.
- Good computer skills.
- Manuscript/document preparation.
Physical Demands/Work Environment
Heavy computer use, domestic travel, and ability to work in an operating room environment without restriction.
1. Internal Contacts: All departments
2. External Contacts: CRO including monitoring team, clinical and reimbursement consultants, medical writers, principal investigators, research site personnel, and regulatory bodies.