Director of Regulatory Affairs - RespirTech (Plymouth, MN)
$171,000–$273,000 year
On-sitePlymouth, Minnesota, United States
Job Summary
Lead Regulatory Affairs strategy end-to-end execution from product inception through lifecycle management for the Philips RespirTech InCourage Vest Therapy. Drive innovation by delivering compliant strategies for new 510k product introductions and changes, while utilizing metrics to inform regulatory and quality decision-making. Manage external relationships with FDA, Notified Bodies, and industry forums to shape the regulatory landscape, and oversee internal audit programs, inspection readiness, and recall efforts. Develop and deploy regulatory resources efficiently, proactively building capabilities within the team and fostering a culture of collaboration across cross-functional partnerships. Represent regulatory affairs on the management team and ensure full compliance with global medical device regulations and internal procedures.
Required Qualifications
- 10+ years of experience working in Regulatory Affairs and/or Quality/Quality Operations within the FDA regulated Medical Device industry
- 3+ years of experience and a strong track record in successfully leading/managing Regulatory Affairs and/or Quality teams
- Extensive experience/knowledge of global medical device regulations, requirements, and standards (ISO 13485, ISO 14971, 21 CFR 820, etc.)
- A proven track record leading cross-functional/diverse teams in a matrix organization, with challenging goals
- Experience working in smaller companies
- Bachelor's Degree (required) in Engineering, Life Sciences, Quality, Regulatory or comparable disciplines
- Experience in building/fostering strategic relationships with external stakeholders (e.g. Notified Bodies, FDA, Competent Authorities)
- Must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position
- US work authorization
- No requirement for sponsorship for a work-authorized visa
- Reside in or within commuting distance to Plymouth, MN
Desired Qualifications
- Experience working in smaller companies
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