Blatchford Group Homepage

Regulatory Affairs Officer

July 5, 2019
Basingstoke
Competitive salary with excellent benefits

Blatchford is a world leading rehabilitation provider with clinical expertise in prosthetics, orthotics, special seating and wheelchairs. We design and manufacture the multi award-winning Endolite range of lower limb prostheses and provide clinical services to the NHS, military and patients internationally. With 128 years of innovation and expertise behind us, we produce the world’s most advanced microprocessor artificial limbs.

We have an exciting opportunity for a Regulatory Affairs Officer, to join our industry leading research and development team based in our rapidly growing facility in Basingstoke.

Working as a Regulatory Affairs Officer involves developing and managing all aspects of pre and post market regulatory compliance matters, including mapping out the regulatory road map across the Blatchford group and our product ranges. You will support the NPD product pipeline by ensuring market access and handling post market surveillance issues, in line with relevant regional requirements.

Responsibilities of the Regulatory Affairs Officer:

  • Interpret MDR, nGMP, Quality assurance for medical devices and FDA rules
  • Manage all regulatory activities to ensure business objectives are compliant.
  • Responsible for submissions and registration of new product.
  • Collaborate with NPD in the development and implementation of new products and technologies, whilst delivering an effective regulatory strategy for group.
  • Act as the regulatory lead for Blatchford, through the provision of training, advice and guidance to ensure all departments are compliant, with required standards.
  • Establish processes for maintenance of registrations, and re-submissions.
  • Assessment, development and implementation of regulatory strategies for changes to manufacturing processes and the export of our products, globally.
  • Maintain regulatory documents/data base as required. Audit Supply chain.
  • Oversee the registration process for new products for different classification of medical devices, and custom build devices and liaise with Notified bodies.
  • Provision of technical file, compliance with competent authorities, contribute to manufacturing and post market controls, including non-conformance corrective
  • Manage budget, develop regulatory briefing documents, attend/host meetings with regulatory bodied and agencies, sub contract services specification.
  • Review and provide proactive solutions to regulatory issues and challenges
  • In conjunction with other teams, support Blatchford’s, post marketing surveillance activities, providing advice and guidance on corrective actions.
  • Maintain awareness of developments and changes in the regulatory environment, worldwide and addressing requirements as appropriate.
  • Participate in relevant Working Groups as expert to develop new standards

Requirements of the Regulatory Affairs Officer:

This is an excellent opportunity for the successful candidate to work in a standalone role; therefore you must be a competent decision maker, with a proactive and pragmatic approach.

You will have strong communication and interpersonal skills, with the ability to liaise, influence and negotiate at all levels. You will have the ability to manage priorities and work proactively and efficiently, leading by example to motivate others. You will be flexible and adaptable in your approach, with strong project management skills.

Experience of working with ISO standards, including ISO 13485 is essential, together with strong, proven experience in document preparation and experience of working with various regulatory bodies and agencies. Experience of working in a regulated industry, such as aerospace, defence, marine or automotive, along with experience of working in the medical device industry is highly advantageous.      

Candidates will hold a bachelor’s degree in a relevant subject, preferably in an Engineering discipline.

How to apply?

We offer competitive salaries, excellent benefits and the opportunity to work in a unique environment, as part of a dynamic R&D team, to drive the success of our award-winning organisation.

If you feel like you meet the above criteria for the Regulatory Affairs Officer, then please apply now!

Please apply by sending your CV to Laura Mann on Recruitment@Blatchford.co.uk or please contact Laura by email for more information.

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