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Regulatory Affairs Officer, Part Time, UK Based Work from home
Our client are an innovative, highly specialised startup surgical technology firm who are looking for an experienced reg affairs officer to join their quality assurance and R&D team.
The company is developing single visualisation software for minimal invasive surgery, and due to the development of the firm have the necessity for a reg affairs officer to take a key role in gaining international regulatory certifications, with a main focus on CE and FDA approval.
It's an incredibly exciting time to join this firm, who have an exciting path and vision for the future and can offer the right candidate the opportunity to develop an outstanding career within the medical imaging space.
If you are a knowledgeable, self-motivated reg affairs officer who has international experience getting medical devices approved across different territories please do get in touch!
In the role of Regulatory Affairs Officer, the main responsibilities are:
- Compile and manage Technical File submission as per MDD (UKCA mark) and MDR to
the Notified Body.
- Liaise and manage with the Notified Body (NB) for product certifications.
- Liaise with the NB for clinical evaluations strategy for the Company's lead product, as
- Review existing requirements specification and identify standards relevant to the
product. Implement a product centric standards library for the company.
- Manage FDA submission and approval.
- Manage country registrations and certificates.
- Initiate and manage risk management file in accordance to EN ISO 14971
- Assist with the implementation and maintenance of the QMS to ISO 13485.
- Work with QA and management to implement and manage SOPs & QMS processes.
- Work with QA to complete and deliver MDSAP
- Guide and assist the R&D Department on product design and development activities.
- Manage a post market surveillance system.
- Manage both internal and external audits
Package and Benefits
- £75 an hour
- Part time 1 - 3 days a week depending on the demands of the business
- Working from home
- Applicants must be EU nationals or have permanent leave to remain in the UK
Key Skills, Qualifications and Client Requirements
- Hold a first or upper class-second class honours degree or equivalent in a scientific or
- Technical background in medical devices working to MDD and MDR
- Experience with FDA submissions and completion
- Experience with MDSAP accreditation
- Competent knowledge of FDA 21 CFR
- Knowledge of the Quality System Regulations to ISO 13485.
- Good communication skills, team leadership and developing staff, drive for results, quality and customer focus, flexibility to cope with rapidly changing priorities
- Demonstrate industrial/commercial experience in the medical device industry
- Good written and oral communication skills in English
Desirable Skills & Abilities
- Implementation and maintenance of medical device technical files (TF)
- Knowledge of other international competent regulatory authorities
- Define quality procedures in conjunction with operating staff
- Appreciation of relevant legal, scientific and manufacturing areas is also necessary
- Good MS Office skills, particularly MS Project and MS PowerPoint
- Proven communication skills, in particular communicating QA information to non QA audiences
What Happens Next?
If you are interested in finding out more about this role please click the 'Apply' button. On submission of the job application form, an email alert is sent to the specialist consultant handling this role to register your interest.
All dialogue with us is in the strictest of confidence, without any obligation and we will NOT send your details to the relevant business without your consent.