What are the responsibilities and job description for the Principal Regulatory Affairs Specialist position at Real?
One of our new cardiovascular client is looking to bring on a tenure Principal Regulatory Specialist to their team. This individual will be responsible for leading global regulatory strategy and execution for innovative medical device products. This role will be instrumental in driving successful market entry and ensuring compliance throughout the product life cycle. The ideal candidate will bring deep expertise in FDA, EMA, and EU MDR regulations, and thrive in a fast-paced, cross-functional environment.
- Lead regulatory strategy for new product development and global market entry, including 510(k), PMA, and CE Mark submissions.
- Prepare, review, and manage regulatory submissions to authorities such as the FDA, EMA, and other global agencies.
- Collaborate cross-functionally with R&D, Quality, Clinical, and Marketing teams to align product development with regulatory requirements.
- Ensure regulatory compliance throughout the product life cycle and proactively monitor changes in global regulations.
- Manage time lines and deliverables across multiple regulatory projects to support successful product launches.
- Bachelor's degree in a scientific, engineering, or related field (RAC certification or advanced degree is a plus).
- Minimum of 6 years of regulatory experience in the medical device industry with a proven track record of successful submissions.
- In-depth knowledge of FDA, ISO, and EU MDR regulatory frameworks.
- Hands-on experience with 510(k), PMA, and CE Marking processes.
- Strong project management, communication, and leadership skills.
- Demonstrated experience in mentoring and cross-functional collaboration.
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EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
In addition to base pay, direct-hire employees may be eligible for client offered benefits such as medical, dental, and vision coverage, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.
To find out more about Real, please visit www.realstaffing.com
Salary : $120,000 - $180,000
