Regulatory Affairs Manager

SkyWater Search Partners; Edina (MN); On-site; USD 80,000 - 110,000; Full time

Job summary

An established industry leader in the medical device sector is seeking a Regulatory Affairs Manager to oversee a dedicated team and drive regulatory strategies. This role offers the chance to impact the business significantly while ensuring compliance with US and EU regulations. With a solid compensation package, excellent benefits, and opportunities for career advancement, this position is ideal for an experienced regulatory affairs professional looking to make a difference in a dynamic environment. Join a forward-thinking company where your expertise will be valued and your contributions will shape the future of medical technology.

Qualifications

• 5+ years of regulatory affairs experience in the medical device industry.
• Experience with US & EU regulatory bodies and compliance.

Responsibilities

• Manage a small team of regulatory and quality professionals.
• Develop regulatory policies and maintain compliance for class II products.
• Act as the regulatory subject matter expert for cross-functional teams.

Skills

Regulatory Affairs

Team Management

Regulatory Compliance

Audit Management

Cross-Functional Collaboration

Education

Bachelor's Degree in Engineering

Bachelor's Degree in Life Sciences

Bachelor's Degree in Business Administration

Job description

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 team, creating regulatory strategies, leading audits, partnering with cross-functional teams & managers, 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 within their organization. We’re looking for an experienced regulatory affairs professional (5+ years) 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

• Manage a small team of regulatory & quality professionals (techs & specialists).
• Develop & implement regulatory policies and procedures. Maintain regulatory compliance for class II products.
• Provide regulatory support for internal and external audits.
• Act as the regulatory subject matter expert and work with cross-functional teams on regulatory projects.
• 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.
• 2+ years of mentoring, leading or managing employees preferred.
• Experience working with US & EU regulatory bodies.