Regulatory Affairs Specialist (Shockwave)

Regulatory Affairs Specialist (Shockwave)

Location: Diegem, Belgium

Duration: March 31, 2026

Hours: 40

As a Regulatory Affairs Specialist, you will be responsible for ensuring regulatory compliance of Medical Devices (MD) as part of the Shockwave portfolio, facilitating seamless local markets access for the Compliance Benelux (Belgium, Netherlands and Luxembourg) and Nordics (Sweden, Finland, Denmark, Norway, Iceland) markets. 

You will also ensure compliance with both local and EU Medical Device Regulation (MDR) regulatory requirements, along with J&J policies pertaining to the entire product lifecycle, including introduction, maintenance, and modifications of products within the Shockwave portfolio, thereby supporting the successful integration of the business.

Roles and responsibilities:

• Ensure regulatory compliance of medical devices to facilitate market access in both the Nordic and Benelux regions.

• Efficiently execute local pre-market regulatory activities, including documentation checks  and system updates, to ensure timely product release.

• Oversee, update, and manage the regulatory database system to maintain local licenses for medical device products and perform distributor activities as required by applicable regulations.

• Identify regulatory concerns related to medical device products and collaborate with relevant stakeholders, including base business, regional, and local teams, to investigate and develop appropriate solutions.

• Provide regulatory support, in collaboration with business and regional Regulatory Affairs teams, to marketing and sales representatives concerning the Shockwave medical device portfolio.

• Collaborate with base business teams and local Commercial, Marketing, Customer Service, Tender, Finance, and Supply Chain teams to ensure a smooth and efficient integration of Shockwave products in the Nordic and Benelux markets.

• Rapidly identifies and reports regulatory concerns to Management and base business, investigate and suggest solutions to resolve issues effectively.

• Performs other duties assigned as needed.

Core competencies:

• Advanced level in Excel

• Rigorous and well organized with attention to detail

• Analytical, self-motivated, energetic and self-disciplined

• Capability of self-awareness and adaptability

• Fast learner, problem solver

• Good communication skills

• Able to work in a high-paced environment

• Ability to analyze, interpret and synthesize regulation and guidelines

• Ability to identify regulatory issues, risks and priorities, and manage them

• Knowledge of EU Medical Device requirements as well as local regulatory requirements for the Nordics and Benelux markets is beneficial

• Previous experience in Medical Devices or Pharma industry is a plus

Required Qualifications:

• Life Sciences degree or Junior Scientist (Pharmacist, Engineer, Biologist, Chemist, etc.)

• Ability to build partnerships internally and externally

• Fluency in English is essential; proficiency in any of the local markets’ languages is a plus (Swedish, Finnish, Norwegian, Danish, Dutch, French or German) 

Benefits:

This role offers a very competitive hourly rate. The contract term ends on March 31, 2026.

About Johnson & Johnson MedTech:

At Johnson & Johnson MedTech, we unleash diverse healthcare expertise, purposeful technology, and a passion for people to transform the future of medical intervention and empower everyone to live their best life possible.

For more than a century, we have driven breakthrough scientific innovation to address unmet needs and reimagine health. In surgery, orthopaedics, vision, and interventional solutions, we continue to help save lives and create a future where healthcare solutions are smarter, less invasive, and more personalised.

https://www.jnj.com/healthcare-products/medtech

Application process:

We are looking to process the first round of applications within the next 2 working days. We do not accept applications via email. The pay rate for this role will depend on how you are paid. PAYE, LTD & Umbrella options are available. 

Diversity, Equity & Inclusion:

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.