Regulatory Affairs Senior Specialist (738950) at CD Diagnostics, Inc in Warsaw, Indiana

Job Description:

Job Summary

Zimmer Biomet is a global medical technology leader. Our team members are part of a company with a heritage of leadership, a focus on shaping the future, and a mission dedicated to alleviating pain and improving the quality of life for people around the world. This position is for CD Diagnostics requires an advanced understanding of In-Vitro Diagnostic (IVD) and medical device products and their use as well as an understanding of the regulatory submissions process.

Principal Duties and Responsibilities

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 which include Pre-Submissions, 510(k)s, IVDR submissions. Primary point of contact for in vitro diagnostic (IVD) and specimen collection kit-related matters, including assisting with product development, classification questions, regulatory submissions, if applicable, as well as reviewing label/labeling, advertisement, promotional, and other customer facing materials for compliance with FDA regulations and guidelines Advise on questions related to compliance with regulations related to IVDR, CLIA Waiver requirements. Acquires and maintains current knowledge of applicable regulatory requirements, including IVD regulations and scientific/technical principles 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 Researches, analyzes and communicates information pertaining to the appropriate regulatory pathway for new or modified products. Interprets results of research 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, EU and international regulations Writes, manages, and approves the development of package inserts and product labeling 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 IVDR and 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 and represents RA in IVDR and MDSAP audits 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.

Expected Areas of Competence

• Thorough working knowledge of all IVD digital health aspects of CE-Marked and FDA-regulated Class I and II medical devices. • Preferably affinity and experience with the development of Software as a Medical Device (SaMD) in the digital health-based diagnostic / IVD arena. • Working knowledge of FD&C Act and CLIA Waiver implementing regulations • Demonstrate 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 orthopedic industry and the marketplace • 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 • Proficient knowledge of FDA and EU IVDR regulations (including labeling regulations) and regulations outside of the US/EU

Education/Experience Requirements

• 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 5-7 years of experience in Regulatory Affairs required • A minimum of 2 years of experience in orthopaedic or in-vitro diagnostic device industry preferred • Previous hands-on experience with the Regulatory processes behind the compilation of 510(k)s, Q submissions, CLIA Waiver highly preferred • Regulatory Affairs Certification (US or EU) preferred • A combination of education, experience, leadership, strategy and RA influence may be considered

Travel Requirements

Up to 15%

Additional Information

At Zimmer Biomet, we believe in The Power of Us, which means that we are stronger together. We are committed to creating an environment where every team member feels included, respected, empowered, and celebrated. As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. This is why we offer you a competitive rewards package that includes medical, dental, vision, life and disability insurance, wellness incentives, employee assistance programs as well as paid time off for vacation and holidays. EOE/M/W/Vet/Disability Compensation range: $98,700 - $122,500