The Senior Regulatory Specialist is responsible for planning, managing, and implementing regulatory submissions to the EU notified body, the US FDA, and other country specific regulatory bodies. The position is also responsible for ensuring continued compliance with regulatory agency approvals including change impact reviews. This position is responsible for complying with the Imricor Quality Management System requirements and carrying out responsibilities as outlined in the environmental, health, and safety policies.
- Develops domestic and international strategies for regulatory approval of company products.
- Coordinates, compiles and submits U.S. and international regulatory filings for new and modified products, including PMAs, 510(k)s, IDEs, CE Marking submissions, and other country specific product registrations.
- Develops and maintains positive relationships with regulatory body reviewers through oral and written communications regarding clarification and follow-up of submissions under review.
- Review of product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings.
- Represents RA on cross functional product development, manufacturing and clinical support teams and provide regulatory feedback and guidance throughout the product development cycle.
- Technical and labeling reviews of supporting documents for inclusion in regulatory filings.
- Represents RA on other cross functional projects which may include process changes and continuous improvement efforts.
- Performs other related duties and responsibilities, as assigned.
- Bachelor of Science in a scientific discipline or equivalent education/ training.
- 5+ years’ regulatory related experience in a regulated industry.
- Previous experience with US and EU medical device regulatory requirements including Quality Systems and clinical investigations standards.
- Australian regulations experience preferred.
- EU MDR transition experience preferred.
- Experience with preparation, submissions and approval for medical devices is required.
- Strong communication skills, both verbal and written.
- Strong analytical and problem-solving skills, as well as a good background in the medical device development process.
- Demonstrated ability to effectively manage multiple projects and priorities.
- Skills in multiple computer-based tools and software such as Word, PowerPoint, Excel, and Adobe Acrobat.
- Light work, exerting up to 20 lbs. of force or less.
- Requires clarity of vision at 20 inches or less (near vision) and ability to identify/distinguish colors.
- Requires typing, talking and hearing.
- 85% of time requires viewing and working at computer screen.
- Travel 15-20%
To apply, please submit a cover letter and resume as one document below.
|Position Reports to:||VP of Regulatory, Quality|