Senior RA Specialist

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 execute 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. 

• Oversee 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. 

• Liaise 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 medicine. 

• Review and approval of translated labelling of medical devices and medicine in local languages. 

• Identify and facilitate continuous improvement activities (self, team, procedures, systems, etc.). 

• Responsible for communicating business related issues or opportunities to next management level. 

• Supervise direct reports; responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable. 

• Responsible for ensuring personal and Company compliance with all local and Company regulations, policies, and procedures. 

• Rapidly identifies and reports regulatory concerns to Management and Base Business investigate and suggest solutions to resolve them. 

• Ensure the execution of POLO Economic Operator Verifications (EOV). 

Performs other duties assigned as needed. 

Authorities 

• Responsible for Nordic Regulatory Affairs compliance. Authorized to make decisions in this area. 

• Required to keep management updated. 

Key Relationships 

• J&J Nordic Leadership team 

• J&J Nordic organization 

• EU Mid-Sized Market Teams 

• EMEAC RA Teams 

• JNJ MedTech Base Business RA and cross-functional Teams 

Key Skills 

Education & Qualifications 

• Required education: University degree within one of the areas of pharmacy, medicine, engineering, or science. 

•  Languages: English and at least one of the Nordic languages. 

Experience, skills and competencies (REQUIRED) 

Please note leadership competencies 

• Positive attitude, well organized with attention to details. 

• Able to work independently with a high degree of integrity. 

• Excellent written and verbal communication skills, presentation & negotiation skills. 

• Able to work well with colleagues across multiple areas of the company and effectively interact with different internal stakeholders. 

• Cultivate relationships with external stakeholders including Trade Associations and Regulators. 

• Able to execute multiple tasks effectively across geographies and Base Businesses 

• Live the credo in a way that creates a trusting, collaboratively and ethical work environment  

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes. 

 Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. 

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource. 

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