Regulatory Affairs Sr Specialist

About the role

This position supports the regulatory process for medical devices and assists with various aspects of the submission and maintenance of regulatory documents.

Responsibilities

• Auxiliary in assembly, distribution, storage, tracking, and retrieval of information pertinent to the regulatory process.
• Authors and publishes electronic submissions.
• Responds to requests from foreign governments and/or distributors to prepare and submit documentation for marketing approval.
• Assists 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, evaluates, 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.
• Maintains awareness of 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.

Requirements

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

Qualifications

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.

Skills

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

Benefits

Flexible working environment
Location specific competitive total rewards
Wellness incentives
Culture of recognition and performance awards

Pay

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

Schedule

Hybrid 3 days at the office

Address

Monteris Medical
131 Cheshire Lane, Suite 100
Minnetonka, MN 55305 US

EEO/M/F/Vet/Disability

Zimmer Biomet is an equal opportunity employer.