The Director of Regulatory Affairs is responsible for the Regulatory strategy for a Class 3, fully implanted artificial pancreas and the associated stabilized insulin. This is a Combination product. The Regulatory Director will have responsibility for planning and requesting pre meetings with FDA and European agencies, submissions for clinical studies, approval, and post market surveillance. All MDR and vigilance reporting and compliance activities will be under the responsibility of this candidate.
TO APPLY: Send Resume/CV and Cover Letter explaining your fit with this position via email to: firstname.lastname@example.org.
Duties and responsibilities
The Regulatory Affairs Director is responsible for the implementation and oversight of all the regulatory activities.
- Oversees all regulatory matters and executes the strategy to ensure the organization complies with applicable regulations.
- Oversees the implementation and completion of regulatory submissions to FDA, EU and other agencies. Manages regulatory projects
- Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements.
- Oversees and maintains documentation on the post-market surveillance, advisory notices and MDR or vigilance reporting.
- Provides updates on strategic regulatory intelligence, such as new regulations, guidance, competitive product applications and approvals, etc.
- Provides tactical support for the timely preparation, editing and review of submissions, including regulatory agency Meeting Requests and Briefing Documents, original PMAs and international Marketing Authorization Applications and their respective amendments/supplements.
- Coordinates and manages regulatory submission documents (e.g., cover letters, Meeting Requests, Meeting Briefing Packages, etc.) to produce submission ready content.
- Develops SOPs and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored.
- Regulatory compliance for labeling and marketing information
- Performs other duties as assigned by the CEO.
- Minimum BA/BS in appropriate discipline
- Minimum Fifteen plus years’ experience in a Regulatory position with minimum of 5 years in a management role. Diabetes, insulin pump, and insulin regulatory experience is desired.
- Requires comprehensive knowledge of US and European regulations for Class 3 devices.
- Must have Device or Drug/device Combination product experience
- Must have experience with FDA and EU submissions.
- Strong verbal and written communication skills with proven negotiation skills.
- Strong in the areas of regulatory affairs, project management, and medical terminology.
- Proven strong negotiation skills dealing with FDA and other regulatory agencies.
- Self-motivated, flexible and individual contributor, strong creative leader, able to prioritize, manage multiple projects, and work in a fast-paced & demanding environment.
- Must be knowledgeable in industry trends for study reports and dossier preparation including electronic document submissions
- Knowledge of safety requirements and legal standards