Director of Regulatory Affairs
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Accentuate Staffing is partnering with a cutting-edge biotechnology company who is hiring for a Director of Regulatory Affairs. This is a direct hire opportunity, offering competitive pay, benefits and stock equity, working a hybrid schedule (two days remote and three days onsite). The ideal candidate has 13+ years of Regulatory Affairs experience, including both device and combination products in the EU and US.
Responsibilities:
- Leading the regulatory affairs department in registrations for new device and combination products by providing strategic regulatory guidance and direction.
- Support medical device operations and drug development teams in support of global product development, life-cycle activities and regulatory agency interactions.
- Achieve successful acceptance of regulatory applications by taking ownership of the management and preparation responsibilities for regulatory submissions to regulatory agencies, this includes both scientific and technical reviews for regulatory compliance.
- Leading all regulatory interactions, serving as the company’s Regulatory Device representative with commercial/development partners and regulatory agencies
Requirements:
- BS Degree in a scientific field combined with 15+ years of Regulatory Affairs experience OR MS Degree combined with 13+ years OR PhD combined with 10+ years.
- 5+ years of leadership experience and highly effective communication skills.
- SME on either device or combination product regulations and guidelines for both the US and EU.
- Proficient using Microsoft Office Suites and document management systems.
