Senior RA Specialist

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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 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.

- Supervis e   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

- EMEA C   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 R egulators.

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

- Live the credo i n 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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Required Skills:

Preferred Skills:
Analytical Reasoning, Business Writing, Coaching, Collaboration, Communication, Legal Support, Problem Solving, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Regulatory Reporting, Risk Assessments, Strategic Thinking

The anticipated base pay range for this position is:
kr659,000.00 - kr1,077,550.00

Benefits:

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.