Regulatory Affairs Sr Specialist (610374) - Fully Remote

Job SummaryZimmer Biomet Dental is a global leader in implant and restorative dentistry solutions with more than 60 years of industry experience. We are proud to be part of one of the largest musculoskeletal companies in the world. Our mission is to alleviate pain and improve the quality of life for people around the world. Every 10 seconds, 24 hours a day, and 7 days a week patients around the world receive a Zimmer Biomet product, resulting in helping millions of people each year. #ZBDentalThe Regulatory Affairs Sr Specialist position requires an advanced understanding of medical devices and their use as well as an understanding of the regulatory submissions process.Principal Duties and ResponsibilitiesAssist with assembly, distribution, storage, tracking and retrieval of information pertinent to the regulatory process; including the regulatory submissions process.Authors and publishes electronic submissionsRespond 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 affiliatesAssist with research, analysis, and communication of information pertaining to the appropriate regulatory pathway for new or modified productsProvides regulatory direction to development project teams as a core team memberDevelops regulatory strategy for new productsEvaluates risk of proposed regulatory strategies and offers solutionsReviews proposed labeling for compliance with applicable US and international regulationsWrites, manages, and approves the development of package insertsReviews, evaluations, and approves promotion and advertising material for compliance with applicable regulationsReviews proposed product changes for impact on regulatory status of the productInterprets and applies FDA regulations to business practices and provides regulatory input, advice, and guidance to the organization and design teamsFollows Zimmer Biomet regulatory affairs policy and proceduresMay provide training and/or guidance to entry-level associates, analysts, interns, and specialistsCommunicates with regulatory and governmental agenciesMiscellaneous responsibilities as assignedExpected Areas of CompetenceDemonstrated strong writing and communication skillsStrong interpersonal skills and attention to detailAbility to manage several competing priorities; versatility, flexibility, and willingness to work with changing prioritiesProficient knowledge of overall business environment, the orthopaedic industry and the marketplaceMastery of relevant regulations pertinent to medical devices, biologics, drugs and combination products as applicableAbility to function well as a member of the team and build relationships between Regulatory Affairs and other areas of the organizationAble to identify risk in regulatory strategiesRobust product knowledgeAdvanced anatomic knowledgeProven analytical and negotiation skillsExperience with solving problems and concernsIntermediate computer skills, including Microsoft Office SuiteAbility to lead a team and influence othersProficient knowledge of FDA and EU regulations (including labeling regulations) and regulations outside of the US/EUEducation/Experience RequirementsUS Bachelors Degree (or non-US equivalent) required; technical/engineering degree, life sciences or related field preferred; alternate degrees may be considered; advanced degree preferredA minimum of 5 years of experience in Regulatory Affairs, Engineering, Quality, or related field requiredA minimum of 2 years of experience in orthopaedic or medical device industry preferredRegulatory Affairs Certification (US or EU) preferredA combination of education, experience, leadership, strategy and RA influence may be consideredTravel RequirementsUp to 15%Additional InformationEOE/M/F/Vet/DisabilityAt 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.Compensation Range: $85,500 - $100,000