Senior RA Specialist

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com . As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Regulatory Affairs Group Job Sub Function: Regulatory Affairs Job Category: Professional All Job Posting Locations: Copenhagen Job Description: DePuy Synthes is recruiting for a Senior RA Specialist, located in Copenhagen, Denmark. Purpose/General summary E nsuring compliance with Medical Device regulations, related legislation, standards, etc. H aving ex pertise in local and EU regulatory requirements for Medical Devices and Drugs . Key responsibilities include managing projects and activities related to the assessment and maintenance of regulatory systems, effectively communicating with key stakeholders, and analyzing regulatory guidelines Duties & Responsibilities Ensure Regulatory Compliance of Medical Devices (MD) facilitating local markets access ( Sweden, Finland, Denmark, Norway, Iceland ) for the full product life cycle – Compliance with both local country requirements and the EU MDR. Provide strategic guidance to the commercial organization related to regulatory requirements and develops recommendations pertinent to the local or bigger business in accordance with local and EU regulations and relevant guidelines. Provide advice, counsel, and expertise on RA issues, both proactively and reactively. Represent the local market and its requirements in various internal forums and stakeholders, including the commercial, regional and global base business organizations. Represent J&J in various internal and external forums such as Trade Associations, meetings with local Health Authorities, etc. Demonstrate deep domain expertise in the regulatory requirements for local and EU registrations, licensing and other RA compliance related matters. Partners closely with internal stakeholders across Johnson & Johnson ( e.g. local commercial organization, central and regional strategy teams) to ensure that the compliance-related requirements are evaluated and executed within the local commercial launch plan strategies. The same applies for product modifications. Analyze, interpret, and synthesize regulations and guidelines, and provide clear and timely communication of new and changing requirements to the base business regulatory teams and updates to the local procedures accordingly. Educate internal stakeholders on local regulatory requirements and integrating those requirements into procedures. Ensure adherence to standard operating procedures and protocols and adjust processes to improve efficiency or align with compliance requirements. Efficiently execut e local Pre-marketing Regulatory activities including documentation check, license updates, system updates to ensure product restriction releases (including MDRIM, RAD, Cignon ). Drive lifecycle initiatives from Regulatory, partnering with the local commercial organization. Overs ee and manage of company license or registration for MDs, Medicine, Veterinary products, and Human Tissue products, including importer and distribution responsibilities as required . Provide regulatory support (in collaboration with business and regional Regulatory Affairs) to marketing, sales representatives, Customer Service, especially for tenders. Support announced and unannounced inspections by Competent Authorities. Liais e with local Competent Authorities. Support Johnson & Johnson Internal Regulatory Compliance Audits. Ensure all post marketing regulatory requirements are met, with an emphasis on ensuring all external communication/marketing materials are compliant with local and regional guidelines and restrictions (Copy review for medical devices and medici