The Director of Regulatory Affairs is a department head who oversees regulatory strategy, operations, and intelligence. They are responsible for developing and implementing regulatory plans throughout the entire product lifecycle. The RA Director has a deep understanding of US, EU, and international regulations for Medical Device products, and works within a cross-functional team to ensure efficient commercialization.
Client Details
This innovative biotechnology company, based in New York develops and sells medical devices that stop bleeding quickly. Their unique plant-based technology achieves this in seconds, eliminating the need for prolonged manual pressure. Their products target the veterinary field, as well as human trauma and surgical applications. Their mission is to save lives.
Description
This Director of Regulatory Affairs will:
- Develop and execute regulatory plans for product development, approval, and launch.
- Manage cross-functional teams to ensure compliance with evolving regulations.
- Lead interactions with regulatory agencies and prepare submissions.
- Collaborate with Quality to ensure product and process compliance.
- Oversee regulatory documentation and lead a regulatory affairs team.
- Stay current on regulatory trends and advise leadersh
Profile
A successful Director of Regulatory Affairs will have:
- Education: A bachelor's degree in a scientific field is required, with a preference for science, engineering, or life sciences (e.g., chemical engineering, biomedical engineering, material science). A master's degree in a relevant field is a plus.
- Experience:
- 8+ years in US medical device regulatory affairs (10+ preferred).
- Proven experience in EU medical device regulatory affairs (years negotiable).
- 5+ years of experience with therapeutic medical devices (excludes diagnostics and instrumentation).
- Management experience in medical device or pharmaceutical quality (2+ years minimum).
- Regulatory Expertise:
- Demonstrated experience leading US marketing applications for Class II/III devices (e.g., 510(k), PMA) as the Official Correspondent.
- Experience with US Q-Submission Meetings and EU Class designation applications (CE marking) as the Official Correspondent (experience negotiable).
- In-depth knowledge of international medical device processes.
- Technical Skills:
- Expertise in biocompatibility requirements (ISO 10993, FDA Guidance, MDR).
- Proficiency in risk assessments (D-FMEA, P-FMEA, BRA, TRA).
- Strong understanding of risk management per ISO 14971.
- Ability to solve technical problems using scientific and engineering principles.
- Scientific Skills:
- Familiarity with analytical chemistry and physical characterization methods for marketing applications.
- Understanding of microbiology methods for marketing applications.
- Compliance:
- Knowledge of US Medical Device Reporting (MDR) regulations (21 CFR).
Job Offer
On Offer for the Director of Regulatory Affairs is:
- Strong Base Compensation and Bonus Plan
- Equity
- 5 Weeks PTO
- Sick Time
- 401k Match
- Commuter Benefits
- Strong opportuntity for career progression
- Meaningful work with life saving devices
APPLY TODAY! All relevant applicants will receive follow up within 72 hours.
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
