Blatchford is a multi-award-winning, global, manufacturer of some of the world’s most advanced prosthetic technology, bespoke seating solutions and orthotic devices.
Our evidence-based approach and commitment to continuously challenge possibilities ensures our mobility solutions prioritise the wellbeing and long-term health of our users. Through science, technology, and maintaining a clear focus on people, we make mobility possible.
We have an exciting opportunity for a Regulatory Affairs Specialist to join our QARA team, initially on a six-month contract to cover maternity leave.
What will you be doing?
As Regulatory Affairs Specialist, you will assist the Regulatory Affairs Manager in the preparation and submission of documents for regulatory agencies. You will support change management and ensure any changes meet applicable regulations and standards.
Key duties:
* Ensuring compliance with regulatory requirements and guidelines (e.g. EU MDR, ISO 13485)
* Providing regulatory review and decision making for changes and support of subsequent actions and document updates.
* Assisting with the preparation and submission of regulatory documents to regulatory agencies
* Maintaining product regulatory files
* Supporting Vigilance and Post-Market Surveillance activities
* Supporting the RA Manager with Regulatory review of new product technical file documentation
What can we offer you?
As Regulatory Affairs Specialist, you will receive:
Benefits
* Highly completive salary
* Flexible, hybrid working.
* 25 days holiday (rising with service)
* Option to purchase additional annual leave.
* Pension
* Death in service
* Discounted shopping and leisure activities
* Health cash plan
* Cycle to work scheme.
* Opportunity to be part of an award-winning organisation with a culture that centres around our core values; courage, learning, integrity, collaboration, and innovation
What are we looking for?
As Regulatory Affairs Specialist, you will have:
Key Skills:
* Previous experience in regulatory affairs in the medical device industry
* Knowledge of UK, EU, US regulations, standards and guidelines
* Experience with compiling regulatory submissions
* Computer literate with good keyboard skills, MS Office experience and SharePoint
* Strong communication skills, this role will require working with various departments across the business and externally
* Strong /organisational skills
* Excellent attention to detail
* Ability to work independently and within a team environment
This is a fantastic opportunity to work as part of a dynamic team, within a unique environment and contribute to the success of our award-winning organisation.
If you feel like you meet the above criteria for the Regulatory Affairs Specialist, then please apply now!