Regulatory Affairs Consultant

4 weeks ago

Oxford UK, Oxfordshire, United Kingdom Life Science People Full time

Job Title: Regulatory Affairs Consultant (Medical Devices & Cosmetics)


Location: United Kingdom (Remote/Hybrid, with occasional travel to Belgium)


About Us:


i am working with a Belgium-based consultancy specializing in regulatory affairs for the medical devices and cosmetics sectors. Their dedicated team assists clients in navigating the regulatory landscape in Europe and internationally, ensuring compliance, product safety, and successful market access.


Key Responsibilities:


  • Provide expert guidance on regulatory requirements for medical devices and cosmetics, with a focus on UK and EU regulations (UK MDR, EU MDR, IVDR, Cosmetic Regulation (EC) No 1223/2009).
  • Prepare and review regulatory submissions, including technical documentation, CE marking, UKCA marking, and product information files (PIFs) for cosmetics.
  • Assist clients in ensuring regulatory compliance during product development, testing, and market entry.
  • Liaise with regulatory authorities such as the UK Medicines and Healthcare products Regulatory Agency (MHRA), the European Medicines Agency (EMA), and notified bodies.
  • Monitor and interpret changes in UK and EU regulatory frameworks for medical devices and cosmetics, advising clients on how these changes may impact their products and strategies.
  • Provide regulatory support for product registrations, renewals, and amendments, ensuring timely submissions and approvals.
  • Conduct regulatory risk assessments and gap analyses to identify potential compliance issues and recommend solutions.
  • Maintain regulatory project timelines and ensure that all deliverables are met within deadlines.
  • Develop and maintain strong relationships with clients, acting as the primary regulatory contact and ensuring smooth communication.


Requirements:


  • Bachelor’s degree in life sciences, pharmacy, engineering, regulatory affairs, or a related field (Master’s preferred).
  • 3+ years of regulatory affairs experience, specifically in medical devices and cosmetics sectors.
  • Strong knowledge of UK and EU regulatory frameworks, particularly post-Brexit UK MDR, EU MDR, IVDR, and the EU Cosmetics Regulation.
  • Experience with regulatory submissions for medical devices (CE marking, UKCA marking) and cosmetics (PIF, safety assessments).
  • Familiarity with classification, labelling, and packaging (CLP) regulations for cosmetic ingredients.
  • Strong project management skills with the ability to handle multiple tasks and meet deadlines.
  • Excellent communication and interpersonal skills in English (knowledge of French or Dutch is a plus).
  • Ability to work independently, demonstrate proactive problem-solving skills, and collaborate effectively with international teams.

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