Regulatory Affairs Project Manager in Warsaw, IN

$80K - $100K(Ladders Estimates)

Zimmer Biomet Holdings   •  

Warsaw, IN 46580

Industry: Healthcare

  •  

5 - 7 years

Posted 65 days ago

This job is no longer available.

Job Summary

This position is responsible for managing all facets of regulatory support to market Zimmer Biomet products, developing regulatory submissions Domestic and International with a focus on US and EU MDR, US Unique Device Identifier (UDI) regulations and evolving UDI global regulatory requirements, the US Medical Device Listing process and Advertising and Promotion regulations to assure regulatory compliance managing departmental projects. In addition, the position will supervise the development and creation of labeling, provide guidance and consultation for domestic and international regulations and interact with governmental agencies. This position focuses on subject matter expertise, and may have responsibility for personnel management.

Principal Duties and Responsibilities

Manages FDA regulatory submission process; may author and publish electronic submissions.

Manages the development of dossiers for registration of products in countries outside the U.S; may author and publish electronic submissions.

Provides regulatory direction to development project teams as a core team member, or lead a project team; develops and communicates regulatory strategy for new products and business development initiatives.

Oversees development of, and may develop and review, proposed labeling for compliance with applicable U.S. and international regulations.

Supports, supervises, and participates (as necessary) in the development of package inserts, evaluation of promotion and advertising material, including social media, for compliance with applicable regulations, and reviews of 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 in areas such as UDI and Medical Device Listing process.

Establishes and reviews Zimmer Biomet RA policy and procedures and ensures compliance with them.

Keeps all areas of Zimmer Biomet informed of regulatory requirements and emerging issues which may affect the registration approval of products.

Communicates with Regulatory agencies.

Responsibility for oversight and prioritization of departmental tasks and projects.

Expected Areas of Competence

Demonstrated strong writing and communication skills; ability to communicate effectively at multiple levels, including with Regulatory agencies, superiors, peers, and direct reports.

Strong attention to details, and ability to multitask.

Understands the overall business environment, the orthopaedic industry and the marketplace.

Mastery of relevant Regulations, and ability stay abreast of regulations pertinent to medical devices, biologics, drugs and combination products.

Strong computer skills.

Able to identify and assess business risks and develop Regulatory strategy.

Strong product knowledge.

Ability to build relationships with other areas of the organization.

Ability to negotiate with Regulatory agencies, management, and other groups as necessary.

Ability to lead a team, influence others and. Strong organizational skills and development project experience qualify the occupant to lead teams and handle increasing levels of responsibilities

Education/Experience Requirements

US Bachelor's (or non-US equivalent) degree in Life Sciences, Engineering or related field

A minimum of 6 years of experience in Regulatory Affairs

oExperience in orthopaedic or medical device strongly preferred

Regulatory Affairs Certification (US or EU) preferred.

Combination of education and experience may be considered

Valid Through: 2019-9-13