Senior Regulatory Specialist

A growing MedTech company is seeking an experienced Senior/Lead Regulatory Affairs Specialist. The ideal candidate will act as the key liaison between the business, its products, and regulatory bodies, with responsibility across pre- and post-market regulatory activities.

We’re looking for someone with practical experience in Medical Technology (Wearables, Monitoring, Software as a Medical Device) quality and regulatory frameworks (including FDA submissions and international standards) who can guide products from development through to market launch and beyond.

Key responsibilities:

• Provide regulatory guidance to internal teams and senior management, supporting the preparation and submission of regulatory documentation.
  
  
• Maintain and update regulatory files and tracking systems to ensure timely access to approval and renewal information.
  
  
• Ensure products comply with regional and international regulations and standards.
  
  
• Keep abreast of evolving legislation, guidelines and industry practices.
  
  
• Analyse and present scientific data to support new product approvals and renewals.
  
  
• Manage submission timelines for licence variations and renewals, ensuring deadlines are met.
  
  
• Prepare and review product labels, patient information leaflets and related documentation.
  
  
• Advise on product testing requirements and interpret clinical and technical data.
  
  
• Offer strategic regulatory input during product development and updates.
  
  
• Lead or coordinate regulatory inspections and audits.
  
  
• Liaise and negotiate with regulatory authorities to secure product authorisations.
  
  
• Support process improvements and provide compliance training and advice to teams.
  
  About You:
  
  
• Experience working within Medical Technology in a regulated environment, ideally including FDA 510(k) submissions and relevant international standards.
  
  
• Strong industry experience operating in a Senior/Lead level role within Regulatory Affairs.
  
  
• Proven ability to manage regulatory processes, from documentation through to communication with authorities.
  
  
• Strong analytical skills and the ability to clearly communicate complex technical and regulatory concepts.
  
  
• Collaborative, organised and able to manage multiple projects and deadlines.
  
  If this role looks like your next challenge, please contact Ben ASAP or apply via this advert!
  
  We endeavour to reply to every candidate, every time but if you haven’t heard back within 10 days, please understand that you have unfortunately been unsuccessful for this