Job #: 11534
Title: Director of Regulatory Affairs
Job Location: Framingham, Massachusetts - United States
Salary: $130,000.00 - $160,000.00 - US Dollars - Yearly
Employer Will Recruit From: Local
Must have medical device background
Relocation Paid?: NO
WHY IS THIS A GREAT OPPORTUNITY?
Our client is a medical device startup developing an innovative, elegant, and superior approach to the rapid cessation of bleeding. They need a Direcvtor of Regulatory Affairs who has Medical Device background and wants to help a startup make a difference. JOB DESCRIPTION
Our client is a medical device startup developing an innovative, elegant, and superior approach to the rapid cessation of bleeding.
The Director of Regulatory Affairs is responsible for developing and managing the regulatory strategy for current and future self-assembling material-based products to ensure the timely preparation of organized and scientifically valid regulatory submissions in various geographic jurisdictions. This individual is also responsible for all regulatory maintenance activities, including periodic reporting requirements for this class II device
- Develop, prepare, execute and manage high quality regulatory strategy, filings and communications for medical devices and potentially pharmaceuticals as required for approvals, commercialization, and compliance.
- Provide guidance, develop and oversee strategy to support approved and planned products.
- Identify additional commercial opportunities.
- Develop, manage and interact with domestic and international regulatory authority personnel, consultants and vendors at appropriate stages of development to ensure success of programs.
- Regulatory representative, including mentoring and directing internal and external regulatory resources and representing the companys regulatory function at regulatory body meetings.
- Represent regulatory strategy to current and potential external partners in business initiatives.
- Develop adequate resources to ensure support of goals and objectives, including implementation and maintenance of systems and procedures to maximize efficiency and compliance.
- Work closely with product development, quality and other teams ensuring regulatory compliance.
- Facilitate environment of cooperation and teamwork to optimize regulatory outcomes.
- BS degree in Biology, Chemistry, Biomedical Engineering or relevant field, Masters preferred
- 10 + years Regulatory Affairs experience with significant exposure to medical or technology devices in a regulated industry.
- Prior PMA submission experience
- Proven track record of success leading products through regulatory approval
- Strong budgeting, problem solving, organizational, planning, analytical and skills.
- Excellent written, verbal, interpersonal communication, leadership skills with attention to detail.
- Goal-oriented, self-motivated, self-directed, requiring little direction.
- Highly committed, flexible, self-confident, and comfortable with uncertainty.
- Fast learner with ability to operate effectively in new environments.
- Commitment to collaborate as a strong team member in a fast-paced environment.
- Ability to gather, integrate, simplify, and explain information from multiple sources.
- Ability to rely on facts and data to assertively influence individuals throughout the company.
- Proactively engage and retain vendors or partners in various countries and cultures.
- Understanding of design controls, quality system, safety regulations, and risk management.
University - Bachelor`s Degree/3-4 Year Degree
How to Apply: