Duration of the contract: 31st December 2026
Essential: 3+ years experience within regularly affairs, within medical device, pharma, biotech, GMP environment
Imagine your next project supporting the heart of MedTech compliance in a dynamic, global environment. As a Regulatory Affairs Specialist, you will play a vital role in ensuring our life-changing innovations reach the patients who need them most by maintaining the highest standards of technical documentation and regulatory alignment.
Roles and responsibilities
You will support the local franchise Regulatory team with a focus on base business support and Life Cycle Management.
This will involve:
* Support preparation of technical documentation or design dossier documentation for submission to and review by Notified Bodies, as assigned.
* Provide regulatory support for Life Cycle Management project as assigned.
* Manage data cleansing and comparison, remediation and maintenance of existing Technical File documentation as instructed and assigned.
* Perform Regulatory Change assessments as assigned.
* Perform Labeling and Promotional Material Reviews as assigned.
How to succeed
We are looking for an open-minded professional who is capable of adjusting to sudden changes and thrives in a fast-paced setting.
You will also bring
* Bachelor or University degree, preferably in Science or Engineering.
* 2–8 years’ experience in a biotechnology or biopharmaceutical (GMP) production environment.
* Strong working knowledge of current Good Manufacturing Practice (cGMP) standards.
* Experience with the use of quality systems (e.g., Comet, TruVault).
* Excellent communication skills in English.
* Familiarity with Annex 1 regulations.
* Experience with Microsoft tools: Excel, Visio, SharePoint, Word, and PowerPoint.
* Additional Dutch language skills.
* Influencing skills and excellent stakeholder management within a highly complex matrix organization.
Benefits
This role offers a very competitive hourly rate. This contract will run for 31st December 2026.
You are welcome here
Johnson & Johnson is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.
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.
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.
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”.
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