Job Description
Regulatory Affairs Specialist - Medical Devices, Hybrid, contract job
Your new company
Our client, a leading player in the medical device sector, is seeking a proactive and detail-oriented Regulatory Affairs Specialist to join their MBD Regulatory Affairs team. Microbiology Division of the Speciality Diagnostics GroupThis is a 5-month contract job.
Your new role
In this pivotal role, you'll support the full product lifecycle, ensuring regulatory compliance across global markets. You'll collaborate with cross-functional teams including Market Access, Commercial, Operations, R&D, QA, and Product Management, as well as engage with regulatory agencies and regional teams.Key Responsibilities:
* Maintain and review regulatory submissions, technical files, and product labelling.
* Assess operational change requests and their impact on licences.
* Respond to customer and commercial enquiries on product classification and regulatory status.
* Support pre- and post-market licence applications across global territories.
* Assist in audit readiness and regulatory planning.
* Stay up to date with global IVD regulations and market intelligence.
What you'll need to succeed
What We're Looking For:
1. Strong communication skills and attention to detail.
2. Proven experience in reg...