Description
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 GroupJob Sub Function:
Regulatory AffairsJob Category:
ProfessionalAll Job Posting Locations:
Diegem, Flemish Brabant, BelgiumJob Description:
Position Summary
The Regulatory Affairs Specialist is responsible for ensuring regulatory compliance of Medical Devices and facilitating market access across Belgium, the Netherlands, Luxembourg, and Nordic markets throughout the full product lifecycle, in accordance with local requirements and EU MDR regulations.
This role provides strategic regulatory guidance to commercial teams, collaborates with regional and global stakeholders, supports market access initiatives, and serves as a key regulatory representative both internally and externally with health authorities, trade associations, and industry organizations.
Key Responsibilities
- Ensure compliance with local and EU regulatory requirements for medical devices and related healthcare products.
- Partner with commercial, regional, and global stakeholders to support product launches and product lifecycle management activities.
- Monitor and communicate new and changing regulatory requirements.
- Educate internal stakeholders on regulatory requirements and compliance obligations.
- Support pre-market regulatory activities, including documentation reviews, license updates, and regulatory system maintenance.
- Drive lifecycle regulatory initiatives in partnership with commercial teams.
- Manage company licenses, registrations, importer responsibilities, and distribution requirements where applicable.
- Provide regulatory support for marketing, sales, customer service, and tender activities.
- Support inspections by competent authorities and act as a liaison with health authorities.
- Participate in internal audits and ensure ongoing regulatory compliance.
- Review and approve translated product labeling and promotional materials to ensure compliance with local and regional requirements.
- Identify and implement continuous improvement opportunities.
- Escalate regulatory risks and propose appropriate solutions.
- Ensure compliance with all company policies, procedures, and applicable regulations.
- Perform additional duties as assigned.
Required Qualifications
Education
- Bachelor's degree in Pharmacy, Medicine, Engineering, Life Sciences, or a related scientific discipline.
Experience
- Minimum 5–6 years of Regulatory Affairs experience within medical devices and/or pharmaceuticals in an international company.
Languages
- Fluent English.
- Fluency in one or more Benelux and/or Nordic languages.
- French language skills are considered an advantage.
Skills & Competencies
- Strong communication and presentation skills.
- Strategic and proactive mindset.
- Deep knowledge of EU and local regulatory requirements for medical devices and pharmaceuticals.
- Ability to influence and communicate effectively with key stakeholders.
- Strong collaboration and stakeholder management skills.
- Results-oriented with a strong sense of urgency.
- Excellent analytical and problem-solving capabilities.
- High degree of adaptability and self-awareness.
Preferred Qualifications
- Advanced degree in Pharmacy, Medicine, Engineering, Life Sciences, or a related field.
Travel Requirements
- Approximately 10% travel.
- Domestic and international travel may be required.
Key Stakeholders
Internal
- EP/NV Base Business Teams
- EMEAC Regulatory Affairs Teams
- EU Mid-Sized Market Team
- GMED
- EMEA Medical Device Compliance Communication Team
External
- National Health Authorities across Benelux and Nordic countries
- Industry Trade Associations
- Third-Party Suppliers
- Third-Party Distributors
- External Working Groups and Regulatory Forums [11_JD_Card...26_draft 1 | Word]
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 ThinkingThe anticipated base pay range for this position is:
€75,500.00 - €117,300.00Benefits:
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.
