Regulatory Affairs Expert
5 days ago
Job Title: Regulatory Affairs Officer – Post Market Surveillance
Cpl Healthcare is seeking a highly skilled Regulatory Affairs Officer to join our team based near Edinburgh. As a key member of our Regulatory Affairs team, you will be responsible for building regulatory strategy, determining applicable regulatory requirements, and proposing solutions to comply with these regulations.
Key Responsibilities:
- Regulatory Strategy and Compliance
- Determine and implement regulatory strategies to ensure compliance with ISO13485, IVD Directive 98/79/EC, IVD 2017/746 Regulation, FDA 21 Code of Federal Regulations (CFRs), Canadian Medical Device Regulations (CMDR) – Part 1, and other country requirements as appropriate.
- Prepare and compile regulatory documentation, coordinate and execute regulatory submissions for countries including the US, EU, Canada, and any other territories as necessary.
- Documentation and Reporting
- Develop product labeling regulatory requirements for products and customer contracted products, including package labels, product labels, and instructions for use.
- Assist in the development of regulatory reports and filings, ensuring coherence and accuracy.
- Liaison and Communication
- Liaise with regulatory authorities and external contract bodies, providing specialized information as required.
- Collaborate with staff and project team members to ensure successful license applications and regulatory submissions.
Requirements:
- A relevant degree and/or relevant work experience in a regulatory affairs environment.
- Previous post-market regulatory surveillance experience (BPDR submission, NDR submission, and FSCA).
- Experience working within an FDA licensed manufacturing facility.
- Ability to prepare coherent regulatory reports and filings.
Benefits:
- Competitive salary: £35,000 - £37,000 per annum, plus benefits.
- Flexible working environment where applicable.
- A range of core and flexible benefits, including pension, private medical cover, life assurance, additional annual leave, cycle to work, technology, experience days, and access to marketplace discounts.
Please note that you must have the full right to work in the UK and be able to work on-site 3 times a week.
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