This position requires an advanced understanding of medical devices and their use as well as an understanding of the regulatory submissions process.

How You'll Create Impact

Assist with assembly, distribution, storage, tracking and retrieval of information pertinent to the regulatory process; including the regulatory submissions process. Authors and publishes electronic submissions

Respond to requests from foreign governments and/or distributors to prepare and submit documentation for marketing approval as well as provide routine regulatory information to associates and affiliates

Assist with research, analysis, and communication of information pertaining to the appropriate regulatory pathway for new or modified products

Provides regulatory direction to development project teams as a core team member; develops regulatory strategy for new products

Evaluates risk of proposed regulatory strategies and offers solutions

Reviews proposed labeling for compliance with applicable US and international regulations

Writes, manages, and approves the development of package inserts

Reviews, evaluations, and approves promotion and advertising material for compliance with applicable regulations

Reviews proposed product changes for impact on regulatory status of the product

Interprets and applies FDA regulations to business practices and provides regulatory input, advice, and guidance to the organization and design teams

Follows Zimmer Biomet regulatory affairs policy and procedures

May provide training and/or guidance to entry-level associates, analysts, interns, and specialists

Communicates with regulatory and governmental agencies

Miscellaneous responsibilities as assigned

This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act.

What Makes You Stand Out

• Demonstrated strong writing and communication skills
• Strong interpersonal skills and attention to detail
• Ability to manage several competing priorities; versatility, flexibility, and willingness to work with changing priorities
• Proficient knowledge of overall business environment, the orthopaedic industry and the marketplace
• Mastery of relevant regulations pertinent to medical devices, biologics, drugs and combination products as applicable
• Ability to function well as a member of the team and build relationships between Regulatory Affairs and other areas of the organization
• Able to identify risk in regulatory strategies
• Robust product knowledge
• Advanced anatomic knowledge
• Proven analytical and negotiation skills
• Experience with solving problems and concerns
• Intermediate computer skills, including Microsoft Office Suite
• Ability to lead a team and influence others

Your Background

• US Bachelor's Degree (or non-US equivalent) required. Technical/engineering degree, life sciences or related field preferred. Alternate degrees may be considered.
• Advanced degree preferred
• A minimum of 5 -6 years of experience in Regulatory Affairs, Engineering, Quality, or related field required
• A minimum of 2 years of experience in orthopaedic or medical device industry preferred
• Regulatory Affairs Certification (US or EU) preferred

Travel Expectations

Up to 15%

Location: Minnetonka, MN

Hybrid 3 days at the office

• Address for the new site Monteris Medical is 131 Cheshire Lane, Suite 100, Minnetonka, MN 55305 US

Salary Range:

$89,607.00 USD - $134,411.00 USD (Annually)