Regulatory Affairs Director Lead in Medical Device Industry
2 weeks ago
About the Role
We are seeking an experienced Regulatory Affairs Director to lead our team in the medical device industry.
This is a unique opportunity to leverage your expertise in regulatory affairs and compliance to drive business growth and improve patient outcomes.
As a key member of our leadership team, you will be responsible for developing and implementing global regulatory strategies, ensuring compliance with international regulations, and collaborating with cross-functional teams to bring new products to market.
Key Responsibilities
- Leverage your extensive knowledge of FDA and other regulatory submissions, including IDE, 510(k), PMA, Technical Files/Design Dossier, and MDD, MDR, MedDev's, ISO 13485 & 14155
- Develop and implement global regulatory strategies to ensure compliance with worldwide regulations and improve product market access
- Collaborate with cross-functional teams, including Marketing, R&D, Clinical, Quality, and Category Leadership to understand patient and market needs and develop creative strategies for bringing new devices and device changes to market
- Drive improvement in regulatory aspects of the Quality System, developing processes and detailing procedures to ensure an effective Quality System
- Provide mentorship on global compliance, focusing on US, EU, Canada, Japan, and China as well as product registrations and clinical evaluations in accordance with applicable regulations
- Ensure compliance with current regulatory procedures and update procedures when new regulatory requirements become effective
- Represent Regulatory Affairs in activities and due diligence concerning potential and executed mergers and acquisitions
Requirements
- Minimum of a Master's Degree in a Life-Sciences discipline (biology, biochemistry, chemistry, microbiology, immunology, pharmacology) or Regulatory/Quality/Health-related discipline(s)
- Minimum of 15+ years' experience working in Regulatory Affairs within medical device/technology environments, with 8+ years' as a functional leader and strong track-record successfully leading a Regulatory Affairs team bringing products to market on time
- Experience with SaMD, AI, and/or digital health is highly desired
What We Offer
We offer a competitive salary range of $180,000 - $220,000 per year, depending on experience, as well as a comprehensive benefits package, including health insurance, retirement plan, and paid time off.
About Lifelancer
Lifelancer is a talent-hiring platform connecting talent with opportunities in life sciences, pharma, and IT. If you're interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Lifelancer.
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