Sarnova - Regulatory Affairs Specialist II
EPM Scientific, Dublin, OH, United States
A rapidly growing medical device organization is seeking a driven and detail‑oriented
Regulatory Affairs Specialist II
to join their Minneapolis team. This is an opportunity to step into a hands‑on role supporting innovative, life‑saving technologies while working closely with cross‑functional partners across product development, quality, and risk management. The ideal candidate brings strong communication skills, a solutions‑oriented mindset, and a passion for navigating complex regulatory pathways.
The Regulatory Affairs Specialist II should have the following qualifications:
Bachelor's degree or Master's degree in Engineering or technical field
5+ years of prior regulatory affairs experience in the medical device field
High proficiency in preparing and filing successful 510k submissions
Willingness to work fully on-site at our Columbus, OH location
Ability to successfully work with cross functional and risk management teams
Regulatory Affairs Specialist II will be responsible for:
In this role, you will provide regulatory support to medical device projects from initial kickoff all the way to post-marketing
Coordinate and prepare global regulatory submission documents with appropriate input from cross‑functional teams
Develop and maintain procedures and work instructions to maintain compliance with applicable regulations
Collaborate with product development teams to support execution of global regulatory strategies
Keep abreast of relevant regulations and inform team about potential impact of changes
#J-18808-Ljbffr
Regulatory Affairs Specialist II
to join their Minneapolis team. This is an opportunity to step into a hands‑on role supporting innovative, life‑saving technologies while working closely with cross‑functional partners across product development, quality, and risk management. The ideal candidate brings strong communication skills, a solutions‑oriented mindset, and a passion for navigating complex regulatory pathways.
The Regulatory Affairs Specialist II should have the following qualifications:
Bachelor's degree or Master's degree in Engineering or technical field
5+ years of prior regulatory affairs experience in the medical device field
High proficiency in preparing and filing successful 510k submissions
Willingness to work fully on-site at our Columbus, OH location
Ability to successfully work with cross functional and risk management teams
Regulatory Affairs Specialist II will be responsible for:
In this role, you will provide regulatory support to medical device projects from initial kickoff all the way to post-marketing
Coordinate and prepare global regulatory submission documents with appropriate input from cross‑functional teams
Develop and maintain procedures and work instructions to maintain compliance with applicable regulations
Collaborate with product development teams to support execution of global regulatory strategies
Keep abreast of relevant regulations and inform team about potential impact of changes
#J-18808-Ljbffr