Regulatory Affairs Manager
SkyWater is partnering with an existing client in Minneapolis 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, regulatory submissions, 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.
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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