Website:
jfamedical.co.uk
Job details:
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.
● Traceability reporting: Prepare and review reports to ensure accurate technical
documentation.
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.
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