Principal Regulatory Affairs Specialist
160 Weymouth Street Minneapolis, MN US
Senior Regulatory Affairs Specialist | Medical Devices | Minneapolis
Join a growing, well established Medical Device company as part of their regulatory affairs team! There are many opportunities for visibility and internal growth with this major name in the industry.
In this role, you play a major role in communicating with the FDA for all regulatory matters. You will have a hand in defining overall regulatory strategy for complex device submissions. The team you are joining is a tight knit team with strong internal partnerships and a culture that rewards innovation and creative thinking. Expect to have a strong hand in managing audits, technical documentation, and for ensuring that all development activities fall within domestic and international standards and regulations.
To be successful in this role, you have strong prior knowledge of medical device regulatory processes and the 510(k) and PMA submission process. Ideally, we would love to see your previous experience bringing innovative or new products to market. If you have experience prepping a company for MDR, that’s a major plus. If you have SaMD or infusion experience, be sure to highlight it as well.
What you will be doing:
- Managing the creation of document packages for regulatory submissions to domestic and international regulatory bodies.
- Providing innovative solutions in a highly collaborative environment to regulatory issues as they arise.
- Developing a robust internal regulatory strategy and playing a key role in maintaining those standards.
What you must have:
- A high level of knowledge of medical device regulatory procedures and submission process.
- A collaborative mindset, ready to join a team that provides help to each other as necessary.
- Incredibly strong communication and technical writing skills.
Years of Experience: 10+
Degree: BS/BA Required
This job description is not intended to be all-inclusive and may have been abbreviated or maximized for online or mobile viewing. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.
Legacy MedSearch was named to the 2019 and 2020 Forbes list of Best Recruiting Firms in America
Meet Your Recruiter
Born and raised in Central Florida, Carolyn is a true Orlando native, graduating from Winter Park High School and the University of Central Florida (Go Knights!) Prior to Legacy, she put her Human Resources Management degree to good use, spending nearly 15 years in a Human Resources Generalist role for a mid-sized manufacturing company.