Regulatory Affairs Specialist: Visa sponsorship

JFA Medical

Position Overview:
JFA Medical Ltd is seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to join our team. The ideal candidate will play a critical role in ensuring the compliance and quality of our medical products through the creation and maintenance of technical files, post-market surveillance, product compliance, and quality control. This position offers support from the director and requires no prior regulatory knowledge, making it an excellent opportunity for individuals with a strong STEM background and a passion for regulatory affairs in the medical field. We would also strongly encourage newly graduated candidates to apply.

Key Responsibilities:

Technical Documentation:

  • Create and maintain comprehensive technical files for all new medical products, ensuring accuracy and compliance with relevant regulations.
  • Regularly update and review technical documentation to reflect any changes in product specifications or regulatory requirements.

Compliance and Quality Control:

  • Monitor and ensure product compliance with all relevant medical device regulations and standards, including those set by MHRA, Trading Standards, and other relevant authorities.
  • Conduct quality control checks at various stages of the product lifecycle, including pre-order, post-production, and periodic QC assessments.
  • Arrange and oversee third-party testing of products where necessary to ensure compliance and safety.

Post-Market Surveillance:

  • Implement and manage post-market surveillance activities to monitor product performance and safety.
  • Collect, analyze, and report on data from post-market surveillance activities to identify trends and areas for improvement.

Regulatory Registrations:

  • Maintain and update EUDAMED registrations for all products, ensuring timely and accurate entries.
  • Liaise with regulatory authorities to ensure all products meet the required registration criteria.

Product Artwork Compliance:

  • Review and approve product artwork to ensure it meets all regulatory and compliance standards.
  • Collaborate with the design and marketing teams to ensure all product packaging and labeling are compliant.

Supplier and Quality Management:

  • Develop and implement robust audit procedures for suppliers and manufacturing partners.
  • Create and manage action plans with suppliers to address quality control issues and ensure continuous improvement.
  • Coordinate with suppliers to ensure adherence to agreed-upon quality standards.
  • Ensure familiarity with ISO9001 standards and conduct internal audits to maintain compliance.

Regulatory Affairs and Documentation:

  • Study scientific and legal documents to ensure product compliance.
  • Keep up to date with changes in regulatory legislation and guidelines.
  • Analyze complex information to ensure product compliance.
  • Obtain marketing permissions, including trademarks worldwide.
  • Outline requirements for labeling, storage, and packaging.
  • Liaise and negotiate with regulatory authorities.
  • Write clear, user-friendly product information leaflets and labels.
  • Create comprehensive product information leaflets.

Travel Requirements:

  • Although based in our Manchester office, weekly trips to Blackpool will be required (up to one to two days a week, depending on requirements), where our warehouse is based.
  • A car and a full driving license are required; mileage will be reimbursed.

Qualifications:

  • A STEM degree background, ideally with a research Master’s or PhD from a Russell Group university or an overseas equivalent.
  • Candidates with an Indian undergraduate degree must have obtained it from an Indian Institute of Technology.
  • Excellent organizational and documentation skills.
  • Strong analytical and problem-solving abilities.
  • Ability to work independently and collaboratively in a fast-paced environment.
  • Exceptional attention to detail and commitment to quality.
  • Strong communication skills, both written and verbal.

Preferred Qualifications:

  • Previous experience in regulatory affairs, quality control, or compliance in the medical device industry is advantageous but NOT required.

What We Offer:

  • Competitive salary
  • Opportunities for professional development and career advancement.
  • Supportive and collaborative work environment.
  • The chance to make a meaningful impact on the safety and quality of medical products.
  • Skilled Worker Visa sponsorship available.

If you are passionate about ensuring the quality and compliance of medical products and are eager to grow your career in regulatory affairs, we encourage you to apply for this exciting opportunity at JFA Medical Ltd

Job Types: Full-time, Permanent, Graduate

Pay: £39,000.00 per year

Benefits:

  • Casual dress
  • Company pension
  • UK visa sponsorship

Schedule:

  • 8 hour shift
  • Day shift
  • Monday to Friday

Work Location: In person

Expected start date: 05/08/2024

To apply for this job please visit www.glassdoor.co.uk.