.Regulatory Affairs Complaint Handling Specialist (f/m/d)Company DescriptionHeadquartered in Basel, Switzerland, the Straumann Group stands at the pinnacle of dental innovation, with a reach spanning more than 100 countries worldwide. We pride ourselves on our expansive network of distribution subsidiaries and partners, showcasing global brands such as Straumann, Neodent, Medentika, DR SMILE, TeethToday, and more. Our mission: To revolutionize dental care, offering a wide range of products, solutions, and services, from dental implants and biomaterials to digital equipment and software.Position SummaryThe Regulatory Affairs Specialist is responsible for identifying and obtaining scientific, engineering, and regulatory information for review, preparation, and maintenance of technical documentation for submission to regulatory authorities in the countries/regions where the company wishes to market medical products. Position holder works with the regulatory authorities, or with the local subsidiaries or distributors taking action on behalf of the company, to ensure compliant market access. In addition, this person is responsible for review of promotional material and labeling for compliance with regulations, overseeing annual establishment registrations and device listings, and supporting on-going compliance projects. The RA Specialist reports to the Head of Regulatory Affairs for ClearCorrect Operating, LLC.Job ResponsibilitiesResponsible for, but not limited to, the followingCoordinate acceptance and management of requests for regulatory activities (i.E., Orbit requests).Generate and review regulatory submissions to obtain compliant market access for distribution of ClearCorrect brand medical products in target markets/regions; may also be called on to support the market access activities of other companies within the Orthodontic Business Unit.Produce subsequent regulatory submissions (renewals, annual reports, change notifications, memos to file, etc.) to maintain market access in the target markets/regions (e.G., maintains Technical Files and associated documentation for European Union).Work with the regulatory authorities (or the local subsidiary or distributor acting on behalf of the company) to achieve market access.Provide input to Product Design teams to assure that regulatory requirements and standards are incorporated in the development process; this may include the preparation and maintenance of the associated Regulatory Strategy.Author, review, and/or approve certain Product Design documentation, in consultation with supervisor, complying with design control requirements to facilitate their use in achieving and maintaining access to the markets in which the company participates.Assess product and manufacturing process changes to determine if regulatory action is required.Support Unique Device Identifier (UDI) requirements in the target markets/regions
