What are the responsibilities and job description for the Regulatory Affairs Specialist II position at EPM Scientific?
A rapidly growing medical device organization is seeking a driven and detailoriented Regulatory Affairs Specialist II to join their Minneapolis team. This is an opportunity to step into a handson role supporting innovative, lifesaving technologies while working closely with crossfunctional partners across product development, quality, and risk management. The ideal candidate brings strong communication skills, a solutionsoriented 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 field5 years of prior regulatory affairs experience in the medical device fieldHigh proficiency in preparing and filing successful 510k submissionsWillingness to work fully on-site at our Columbus, OH locationAbility to successfully work with cross functional and risk management teamsRegulatory Affairs Specialist II will be responsible forIn this role, you will provide regulatory support to medical device projects from initial kickoff all the way to post-marketingCoordinate and prepare global regulatory submission documents with appropriate input from cross-functional teamsDevelop and maintain procedures and work instructions to maintain compliance with applicable regulationsCollaborate with product development teams to support execution of global regulatory strategiesKeep abreast of relevant regulations and inform team about potential impact of changes
Salary : $30 - $35