What are the responsibilities and job description for the Regulatory Affairs Manager position at SkyWater Search Partners?
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Posted: February 28,2025
SkyWater is partnering with an existing client in the Southwest metro to find a Regulatory Affairs Manager for their team! The Regulatory Affairs Manager will be responsible for overseeing a small regulatory team, developing & implementing regulatory strategies for the organization, leading regulatory audits, partnering with company leadership & cross-functional managers on strategic initiatives, and much more. Our client is an industry leading medical device manufacturer who’s offering a solid compensation package (base bonus potential), excellent benefits, and opportunities to advance your career with their organization. We’re looking for an experienced regulatory affairs professional (5 years), someone with team leadership experience (direct or indirect), and someone with experience working with US & EU regulatory bodies. If you’re looking for an exciting opportunity to join an industry leading company where you can make an impact on their business, then please submit your resume to be considered!
Responsibilities
Develop & implement regulatory policies and procedures.
Maintain regulatory compliance for class II medical device products.
Provide regulatory support for internal and external audits.
Manage a small team of regulatory & quality professionals (techs & specialists).
Maintain knowledge of regulatory changes and stay up to date on US & EU markets.
Compile, prepare and submit regulatory submissions to US & EU agencies as needed.
Other projects or responsibilities as assigned.
Desired Skills And Experience
Bachelor’s Degree in engineering, life sciences, business administration, or a related field.
5 years of regulatory affairs experience and experience working in the medical device industry (class II products preferred).
1 year of mentoring, leading or managing employees (directly or indirectly).
Experience working with US & EU regulatory bodies.
Strong communication skills (both verbal & written).
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