Regulatory Affairs Specialist

3 days ago


Eastern England, United Kingdom Medella Life Full time

Job Title: Regulatory Affairs Specialist (12-month Contract)


Location: Hybrid - Cambridge, UK


Overview: We are seeking a highly motivated and experienced Regulatory Affairs Specialist to join our team on a 12-month contract basis. The successful candidate will play a crucial role in ensuring regulatory compliance within the Medical Device sector, with a focus on In Vitro Diagnostics (IVD). The position will be based in our Cambridge office, offering a hybrid work arrangement.


Key Responsibilities:


Regulatory Compliance:

  • Ensure compliance with relevant regulatory standards and guidelines in the Medical Device sector, with a specific emphasis on IVDs.
  • Monitor and interpret changes in regulations to ensure the company's products meet all requirements.


Submission Management:

  • Prepare and submit regulatory documents, including 510(k) submissions, CE Mark applications, and other regulatory filings.
  • Collaborate with cross-functional teams to gather necessary information for regulatory submissions.


Quality System Support:

  • Contribute to the development and maintenance of the company's quality management system to ensure ongoing compliance.
  • Participate in internal and external audits related to regulatory affairs.


Product Lifecycle Management:

  • Support regulatory aspects of product development from concept through commercialisation.
  • Provide regulatory input to product development teams and ensure compliance throughout the product lifecycle.


Communication and Collaboration:

  • Liaise with regulatory authorities, notified bodies, and other relevant stakeholders.
  • Collaborate with internal teams, including R&D, Quality Assurance, and Marketing, to achieve regulatory goals.


Qualifications:

  • Bachelor's degree in a relevant scientific or engineering discipline.
  • Proven experience in Regulatory Affairs within the Medical Device sector, with specific exposure to In Vitro Diagnostics (IVDs).
  • Strong understanding of regulatory requirements, including FDA regulations, EU MDR, and other global regulatory frameworks.
  • Experience with preparing and submitting regulatory documents and interacting with regulatory agencies.
  • Excellent communication and interpersonal skills.


Desirable Skills:

  • Familiarity with international regulatory requirements for medical devices.
  • Previous experience in a hybrid work environment.
  • Certifications in Regulatory Affairs would be an advantage.


Duration and Compensation: This is a contract position with a competitive rate with experience and qualifications. The selected candidate may have the opportunity for extension or permanent employment based on performance and company needs.

We look forward to receiving applications from qualified individuals who are passionate about maintaining high-quality standards and driving continuous improvement within our organisation.



  • Eastern England, United Kingdom Medella Life Full time

    About Medella LifeWe are a company committed to delivering high-quality medical devices that meet the highest standards of regulatory compliance. Our team is seeking an experienced Regulatory Affairs Specialist to join us on a 12-month contract basis.


  • England, United Kingdom Medella Life Full time

    Job Title: Regulatory Affairs Specialist (12-month Contract)Location: Hybrid - Cambridge, UKOverview: We are seeking a highly motivated and experienced Regulatory Affairs Specialist to join our team on a 12-month contract basis. The successful candidate will play a crucial role in ensuring regulatory compliance within the Medical Device sector, with a focus...


  • England, United Kingdom Medella Life Full time

    Job Title: Regulatory Affairs Specialist (12-month Contract)Location: Hybrid - Cambridge, UKOverview: We are seeking a highly motivated and experienced Regulatory Affairs Specialist to join our team on a 12-month contract basis. The successful candidate will play a crucial role in ensuring regulatory compliance within the Medical Device sector, with a focus...


  • England, United Kingdom Medella Life Full time

    Job Title: Regulatory Affairs Specialist (12-month Contract) Location: Hybrid - Cambridge, UK Overview: We are seeking a highly motivated and experienced Regulatory Affairs Specialist to join our team on a 12-month contract basis. The successful candidate will play a crucial role in ensuring regulatory compliance within the Medical Device sector, with a...


  • Eastern England, United Kingdom CHASE Full time

    Job Title: Regulatory Affairs ProfessionalWe are seeking a highly skilled Regulatory Affairs professional to maintain product licences held by our client, ensuring new licence applications are submitted appropriately and that licences are kept up to date with the relevant Regulatory Authorities.This role is home-based in North West England, working as part...


  • England,, UK, United Kingdom RRxCo.™ Full time

    RRxCo is seeking a Regulatory Affairs Consultant to assist with a 12-month initial project for a leading Medical Device (Medtech) manufacturer to support several activities in the overall program. The program will based in the United Kingdom, with some onsite presence needed at one of their sites in the Midlands (for the first 6 months, ideally 3 days a...


  • South East England, United Kingdom Page Group Full time

    Exciting opportunity to join a growing pharamceutical business to a newly formed role as Regulatory Affairs And Pharmacovigilance Specialist. **Client Details** My Client is a fast growing pharmaceutical business who own and commercialise branded, original over the counter products and prescription medicines. Products are available in more than 60...


  • Eastern England, United Kingdom Focus Management Consultants Full time

    Job Description:We are seeking a highly motivated EU Food Regulation Specialist to join our team at Focus Management Consultants. As a key member of our regulatory affairs department, you will be responsible for ensuring compliance with EU food regulations across our EU operations.This is an excellent opportunity for a detail-oriented and organized...


  • England, United Kingdom Cpl Life Sciences Full time €35,000 - €40,000

    Job Title: Regulatory Affairs Officer Job Type: Full-time, permanent position Location: Outskirts of Edinburgh, Scotland, UK – 3x a week on site. (Relocation support can be offered for the right candidate, however you MUST have the full right to work in the UK) Remuneration: £35,000 to £40,000 + benefits An exciting opportunity to join an...


  • England, United Kingdom Cpl Life Sciences Full time

    Job Title: Regulatory Affairs OfficerJob Type: Full-time, permanent positionLocation: Outskirts of Edinburgh, Scotland, UK – 3x a week on site. (Relocation support can be offered for the right candidate, however you MUST have the full right to work in the UK)Remuneration: £35,000 to £40,000 + benefitsAn exciting opportunity to join an established and...


  • England, United Kingdom Cpl Life Sciences Full time

    Job Title: Regulatory Affairs OfficerJob Type: Full-time, permanent positionLocation: Outskirts of Edinburgh, Scotland, UK – 3x a week on site. (Relocation support can be offered for the right candidate, however you MUST have the full right to work in the UK)Remuneration: £35,000 to £40,000 + benefitsAn exciting opportunity to join an established and...


  • South East England, United Kingdom Nursing and Midwifery Council Full time

    We are seeking a highly skilled Regulatory Affairs Specialist to join our General Counsel team at the Nursing and Midwifery Council. As a Senior Lawyer, you will play a key role in providing high-quality legal advice and support to the organisation on complex regulatory and corporate matters.The successful candidate will have excellent analytical and...


  • South East England, United Kingdom TEVA Full time

    We are a leading manufacturer of innovative and generic medicines, operating in nearly 60 countries worldwide. As a Regulatory Affairs Expert, you will play a critical role in ensuring the quality and safety of our products.About the JobThe successful candidate will have a strong background in regulatory affairs and excellent communication skills. Key...


  • South East England, United Kingdom WALKER COLE INTERNATIONAL LTD Full time

    You will be responsible for: - Liaising with both internal and external stakeholders to ensure all regulatory requirements are met. - Co-ordinating and submitting PSURs and preparing responses to questions from Regulatory Authorities. - Monitoring product safety information, maintaining product labelling and reviewing artworks for use in submissions. - At...


  • Eastern England, United Kingdom SUN PHARMA Full time

    About the RoleWe are seeking a Medical Affairs Specialist to join our team in the UK, responsible for supporting the development and execution of medical strategies for our oncology products.The ideal candidate will have a strong background in medical affairs, with experience in leading medical pre-launch and launch activities in the UK, as well as a proven...


  • Eastern England, United Kingdom tranScrip Full time

    Job Description tranScrip is a leading pharmaceutical consultancy with over two decades of experience in delivering successful development programs and regulatory submissions for more than 500 clients worldwide. As the Head of Drug Safety, you will play a crucial role in building and maintaining tranScrip's expertise in drug safety, ensuring high-quality...


  • Eastern England, United Kingdom MCG Talent Full time

    We are seeking a highly experienced Director of Public Affairs and Reputation Management to join our team in Dubai, Bahrain or Riyadh. The ideal candidate will have a proven track record of developing and executing successful communication strategies in a government advisory setting.The estimated salary for this position is $110,000 - $160,000 per year,...


  • South East England, United Kingdom Page Group Full time

    Exciting Opportunity to join a growing Product Development and Regulatory Consultancy as a Prinicpal Consultant / Regulatory Affairs Director. **Client Details** My client is a fast growing and leading Product development and Regulatory Consultancy. Remote Working **Description** Principal Consultant / Regulatory Affairs Director - Provide strategic,...

  • Head of Quality

    4 weeks ago


    England, United Kingdom Laraveldaily Full time

    At Dräger we protect, support and rescue lives day in and day out. We are interested in you if you have the desire to work for an organisation that does something more, something that is truly worth working for. As an international leader in medical and safety technology, we develop pioneering devices, software, services and solutions that people around...


  • Eastern England, United Kingdom Focus Management Consultants Full time

    Job Overview:We are seeking a highly skilled EU Food Regulation Specialist to join our team at Focus Management Consultants. As a key member of our regulatory affairs department, you will be responsible for facilitating closer collaboration among our EU operations.This is an excellent opportunity for a motivated and experienced Regulatory Compliance Expert...