Regulatory Affairs Officer
2 months ago
REGULATORY AFFAIRS OFFICER BIOTECHNOLOGY LIFE SCIENCES MEDICAL DEVICES OR PHARMACEUTICALS
BASED EDINBURGH – SALARY EXCELLENT PLUS BENEFITS / HYBRID WORKING
The product range includes in vitro diagnostics and medical devices for use in clinical laboratories throughout the world. The organisation also offers contract services to the bioscience industry and currently manufactures products for major global players in the Life Sciences sectors.
They are recruiting for a Regulatory Affairs Officer to join their Regulatory Affairs & Quality team; the role is a full permanent position working flexible working hours and with hybrid working. You will be responsible for building regulatory strategy, applicable regulatory requirements, solutions to comply with regulatory requirements and managing product license registration with the appropriate regulatory authorities worldwide.
Prepare, write and compile regulatory documentation, coordinate and execute regulatory submission with FDA, European Notified Bodies, Health Canada etc.
Review analytical data from development studies and performance evaluation studies
Advise staff / project team members on data and information required for successful license applications and co-ordinate efforts to ensure the standard for submission.
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), Canadian Medical Device Regulations (CMDR) etc.
Liaise with regulatory authorities and external contract bodies and, in response to requests from these, to collate and interpret specialised information;
Actively participate in product development projects in order to provide guidance on regulatory requirements and to provide supporting regulatory documentation.
Ensure that changes are documented in accordance with quality system requirements and are communicated in a timely basis as appropriate to the Regulatory Authorities;
Assist with the implementation of the Quality Policy to ensure compliance with Good Manufacturing Practice (cGMP), 13485 standards the 98/79/EC IVD Directive, IVD 2017/746 Regulation, FDA Regulations, Health Canada Medical Device Regulation etc.
You should hold a relevant degree and/or have work experience in a Regulatory Affairs environment; with the ability to prepare coherent regulatory reports and filings; You will need to handle external communication with staff from regulatory bodies, customers, distributors and labelling and packaging suppliers and be proactive and able to work effectively both independently or within a team, participating in R&D project teams as required and deliver end results.
This is an excellent chance to join a thriving and highly successful expanding Scottish business, part of a much larger UK based blue chip business, launching new products and a medical device and volume manufactured consumable. A competitive basic salary is on offer with a comprehensive benefits package including company pension, healthcare and company bonus.
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