Regulatory Affairs Specialist

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]