Regulatory Affairs Specialist - Hays Specialist Recruitment Limited : Job Details

Regulatory Affairs Specialist - Medical Devices, Hybrid, contract jobYour new companyOur 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 roleIn 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 succeedWhat We're Looking For:

• Strong communication skills and attention to detail.
• Proven experience in regulatory affairs within medical devices or IVD.
• Ability to manage multiple priorities in a fast-paced, matrixed environment.
• Proficiency in SAP, MasterControl, and Microsoft Office Suite.
• A self-starter with a collaborative mindset and a passion for continuous improvement.

What you'll get in returnFlexible working options available.What you need to do nowFor more information on this or any other Regulatory Affairs contract jobs, please apply for this advert.