Regulatory Affairs Lead

About us

KYMIRA® is one of the world’s leading smart textile companies and a multi-award-winning innovator – developing products and technologies that help, change, and ultimately save people’s lives. Our goal is to save or positively impact 1,000,000 or more lives by 2030 and become a globally recognised brand, solidifying our position as the global leader in the smart garment and textile industries.

The team strive to solve and improve large societal issues and are working in partnership with leading institutions such as the European Space Agency, Innovate UK, Universities, and the NHS, to research cutting edge technologies and e-textiles. The company works within the Medical, Sport, Defence and Space verticals, across B2B and consumer markets. By blending technology with biology in perfect synergy, we are able to release and enhance human ability.

KYMIRA products are used by Olympic athletes, elite teams, and recreational athletes alike, even world record explorers! This is alongside medical professionals, patients, and research institutions. Profits from sales are reinvested into new medical research, as we strive for a healthier and safer tomorrow.

Job Summary

KYMIRA is looking for a Regulatory Affairs Lead to develop and deliver our RA/QA strategy.  The successful candidate will fulfil a lead role, managing key RA/QA activity whilst also leading the operational work to deliver new product approvals for our exciting and unique active medical devices. You will be working closely with our Senior Leadership Team to execute our RA/QA roadmap, driving towards achieving our 2030 goal of positively impacting no less than 1,000,000 lives.

We are looking for someone with at least 3 years of regulatory affairs experience in EU and US medical devices and at least 1 year of management/lead experience. The successful candidate will be a mission driven, team playing forward thinker that can take key direction and deliver.

It is an exciting time for the company as we receive new funding and investment to commercialise and roll out multiple new products, innovated by our technology team, over the next 18 – 24 months.

You Will

  • Develop and manage the RA/QA roadmap aligned to strategic objectives.
  • Develop and support governance of a QMS compliant to ISO 9001:2015, ISO 13485:2016 and FDA 21 CFR Part 820.
  • Manage the full lifecycle of FDA and CE product submissions.
  • Create and manage technical files compliant to MDD 93/43/EEC and MDR 2017/745 up to Class IIa devices.
  • Act as lead auditor, conducting internal and external audits (system, process, product).
  • Support clinical research work (e.g., MHRA submissions).
  • Work with other departments to develop and maintain quality levels.
  • Provide RA/QA insight and guidance to rest of the business.

You Are

  • Socially and mission driven
  • Highly motivated with a strong work ethic
  • Capable of working under pressure in order to meet tight deadlines, ensuring attention to detail at all times.
  • An excellent communicator across all arenas and platforms
  • Able to create a fast paced and technically astute team.
  • Confident in communicating with internal and external stakeholders of all levels
  • Someone who thrives in a high-pace and agile scale-up environment
  • Able to work effectively independently and as part of a team
  • Organised with your work operations, prioritisation and time management skills
  • Strategically savvy and can deliver tactically and operationally.

You Have

  • Proven experience in the medical device industry, preferably with active diagnostics and/or remote monitoring solutions.
  • Initiative, with a proactive attitude to meeting strategic milestones
  • A minimum of 3 years of regulatory affairs experience in EU and US medical devices and at least 1 year of management/lead experience.
  • Proven experience working to a QMS compliant to ISO 13485 and FDA 21 CFR Part 820.
  • Proven experience of successfully delivering FDA and CE product submissions up to Class II(a) devices.
  • Strong demonstrable understanding of MDD 93/43/EEC and MDR 2017/745.
  • Proven experience as a lead auditor or team member.

Ideally, You Will Also Have

  • Prior start-up/scale-up experience is a huge plus
  • An understanding of US medical reimbursement regulations.
  • An understanding of relevant supporting medical device standards (e.g., ISO 14971:2019 IEC 62304:2006).

Remuneration and Benefits

  • Annual Salary of £40,000 – £60,000 (dependant on experience) with long term development prospects.
  • Employee options scheme.
  • Ongoing professional development support.
  • Discounts on popular brands, thanks to employee benefits.
  • New starter credit and staff discounts on KYMIRA products.
  • 28 days’ annual leave, plus your birthday off!

Other Information

  • Desired start date: ASAP.
  • Place of work: KYMIRA HQ, Reading, RG1 with Remote working available per company policy.
  • Permanent Position: Full Time or Part Time (at least 3 days/week) available.

 

To apply, please e-mail your CV and cover letter to nick@kymira.co.uk