Regulatory Affairs Expert
3 days ago
Regulatory Affairs Officer Role
Cpl Healthcare is seeking a skilled Regulatory Affairs Officer to support our growing Regulatory Affairs Department. As a key member of our team, you will be responsible for building regulatory strategy, determining applicable regulatory requirements, and proposing solutions to comply with regulatory requirements. Your expertise will ensure the success of our product license registrations with the appropriate regulatory authorities worldwide.
Key Responsibilities:
- Prepare and compile regulatory documentation, coordinate and execute regulatory submissions in compliance with ISO13485, IVD 2017/746 Regulation, FDA 21 Code of Federal Regulations (CFRs), Biologics License Applications (BLA), Medical Device Approvals (510(k)), Canadian Medical Device Regulations (CMDR) – Part 1, and other country requirements as necessary.
- Advise staff and project team members on data and information required for successful license applications and coordinate their efforts to ensure their contributions to regulatory applications meet the required standards for submission.
- Develop product labelling regulatory requirements for products and customer-contracted products, including package labels, product labels, and instructions for use.
- Contribute to the regulatory watch process by maintaining knowledge of new or updated regulatory requirements, guidance documents, and industry standards.
- Ensure maintenance of product regulatory documents and technical files (including US, EU, Japan, Brazil, Canada) to ensure ongoing compliance with ISO13485, IVD Directive 98/79/EC, IVD 2017/746 Regulation, FDA 21 Code of Federal Regulations (CFRs), Biologics License Applications (BLA), Medical Device Approvals (510(k)), and Canadian Medical Device Regulations (CMDR).
- Provide support to the Department Leader of Regulatory Affairs with regards to planning and coordination of activities and training and supervision of other members of the Regulatory Affairs team to ensure continuous development of junior staff.
Requirements:
- A relevant degree and/or relevant work experience in a regulatory affairs environment.
- Experience in a medical device / IVD / biotech industry.
- Previous experience preparing and submitting BLA, 510(k), PMA, CE mark, and technical files to other worldwide regulatory authorities.
- Ability to prepare coherent regulatory reports and filings.
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