Senior RA Specialist at 7070-Janssen-Cilag A/S Legal

About The Role

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

Ensuring compliance with Medical Device regulations, related legislation, standards, etc.Havingexpertisein 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)facilitatinglocal markets access (Sweden, Finland, Denmark, Norway, Iceland) for the full product life cycle – Compliance with both local country requirements and the EU MDR.

Providestrategic guidance to the commercial organization related to regulatory requirements anddevelopsrecommendations pertinent to the local or bigger businessin accordance withlocal and EU regulations and relevant guidelines.

Provide advice, counsel, andexpertiseon RA issues, both proactively and reactively.

Representthe local market and itsrequirementsin various internal forums and stakeholders, including the commercial,regionaland globalbasebusiness organizations.

Represent J&J in various internal and external forums such as Trade Associations, meetings with local Health Authorities, etc.

Demonstratedeep domainexpertisein the regulatory requirements for local and EU registrations,licensingand 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 andtimelycommunication 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 andintegratingthose requirements into procedures.

Ensureadherence to standard operating procedures and protocols and adjust processes to improve efficiency or align with compliance requirements.

Efficiently executelocal Pre-marketing Regulatory activities including documentation check, license updates, system updates to ensure product restriction releases (including MDRIM, RAD,Cignon).

Drivelifecycle initiatives from Regulatory, partnering with the local commercial organization.

Overseeandmanage ofcompany license or registration for MDs, Medicine, Veterinary products, and Human Tissue products, including importer and distribution responsibilities asrequired.

Provide regulatory support (in collaboration with business and regional Regulatory Affairs) to marketing, sales representatives, Customer Service, especially for tenders.

Supportannounced and unannounced inspections by Competent Authorities.

Liaisewith 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.

Identifyandfacilitatecontinuousimprovementactivities (self, team, procedures, systems, etc.).

Responsible for communicating business related issues or opportunities tonextmanagement level.

Supervisedirect 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 andreportsregulatory 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 RegulatoryAffairscompliance. Authorized to makedecisionsin this area.
-
Required to keep management updated.

Key Relationships

-
J&J Nordic Leadership team
-
J&J Nordic organization
-

EUMid-SizedMarket Teams

EMEACRA Teams

-
JNJ MedTech Base BusinessRAand cross-functionalTeams

Key Skills

Education & Qualifications

Required education:University degree withinone of the areasof 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& negotiationskills.

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

Cultivaterelationships withexternal stakeholders including Trade Associations and Regulators.

Able to execute multiple tasks effectively across geographies andBase 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.

#LI-Hybrid

#DePuySynthesCareers

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.