Regulatory Affairs Officer
About Our Client
Our client is a multinational company developing innovative medical technologies.
- Prepare, write and compile regulatory documentation, coordinate and execute regulatory submission with FDA, European Notified Bodies, Health Canada and any other territories as appropriate;
- Review analytical data from development studies and performance evaluation studies to ensure regulatory requirements are met;
- Advise staff and project team members on data and information required for successful license applications and co-ordinate their efforts to ensure that their contributions to regulatory applications are produced to an appropriate 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) C Part 1 and other non-registered product requirements to support compliance for the company and its products;
- 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 on a regular basis 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 Company's 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, Part 1, Good Clinical Practice (GCP) and approved Health and Safety Policies.
The Successful Applicant
- A relevant degree and/or relevant work experience in a regulatory affairs environment;
- Ability to prepare coherent regulatory reports and filings;
- Sound knowledge and expertise with core IT packages i.e. MS Office;
- Clear spoken and written communication;
- Effective external communication with staff from regulatory bodies, customers, distributors and labelling and packaging suppliers;
- Proactive and able to work effectively independently or within a team, participating in R&D project teams as required and deliver end results under tight timelines;
- Great attention to detail with a thorough and methodical approach to work. Ability to analyse information in a structured manner;
- Ability to work under pressure of a high workload, meet deadlines and respond flexibly;
- Effective time management and prioritisation skills;
- High sense of responsibility and accountability to ensure compliance and to inspire colleagues to do the same;
- Adequate leadership skills in order to be able to take on a supervisory role when required/appropriate;
- Good business acumen;
- Fluent in English.
What's on Offer
Great opportunity to strengthen pre-market skills with global scope of responsibilities.
PageGroup is an equal opportunity employer committed to workforce diversity, both as an employer as well as a recruitment service provider. Each recruitment decision we make for people we hire and people we place into new roles is based solely on the candidates’ knowledge, experience and skills.