Job Description

Are you a regulatory affairs specialist with experience in PMA submission? Looking to make a real impact in a forward-thinking, expanding company? We want to hear from you!

Amber Therapeutics are looking for a proactive and passionate

Senior Regulatory Affairs Associate

to play a pivotal role in ensuring our active implantable medical device meets global regulatory requirements. This is a remote role with monthly onsite visits, although there could be provisions for more regular office attendance if preferred at our new custom-built facility at Harwell, Oxfordshire. Amber is a pioneering neuromodulation company dedicated to transforming the lives of patients through advanced medical technology.

The Role

You will take the lead on submissions, support product lifecycle management, and act as a key contact for both internal teams and regulatory bodies in a fast-paced working environment.

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ou will be responsible for PMA submissions and therefore must have previous exposure and an understanding of what is needed to take them through to approval.

Key Responsibilities:

Help to shape global regulatory strategy to support product development, market entry, and lifecycle management. Provide regulatory input into business planning, risk assessments, and commercial go-to-market decisions. Identify the best regulatory pathways including MDR, UKCA, FDA 510(k)/PMA for new products and modifications. Prepare, review and manage submissions: MDR Tech Files, UKCA, FDA 510(k)/PMA, Canada, TGA etc. Compile, maintain and update Design Dossiers & Technical Files in line with regulations and product changes. Stay on top of global regulatory shifts (MDR, IVDR, FDA, ISO 13485/14971). Participate in the review and development of SOPs, policies, and templates. Be the primary regulatory contact in project teams ensuring alignment between functions and providing regs input throughout the product lifecycle. Partner closely with Quality & R&D on design control, risk and change management.

Skills & Experience

Degree in Life Sciences, Engineering or related or equivalent experience Proven experience in regulatory affairs, preferably within medical devices In-depth knowledge of EU MDR, FDA regulations and ISO 13485 is essential Proven experience in PMA submission is essential Proven track record of managing global submissions (US, EU, UKCA, APAC etc) Strong technical writing, organisational and project management skills Ability to work collaboratively and influence across functions Experience working in a fast-paced or scaling organisation is desirable


A clear, confident communicator, with a collaborative mindset and a strong work ethic, you will have excellent interpersonal skills, and thrive in a fast-paced, multi-disciplinary environment.

About Us

Amber Therapeutics is developing a closed-loop neuromodulation therapy able to treat mixed urinary incontinence for the first time and transform the clinical outcome of a very large untreated patient population. Amber's fully implantable PicostimTM System targets the pudendal nerve with a device that can both stimulate and sense physiological responses. Please refer to our website for further information.

What We Offer

This is a chance to be part of a ground-breaking team creating life-changing therapies for millions of people globally. You join us at an exciting phase of our development, as we expand the team and accelerate towards our first Pivotal Trial. In addition, we offer a competitive salary commensurate with experience, private healthcare, income protection, life assurance, company pension scheme and 27 days holiday (plus bank holidays).



Amber Therapeutics is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Apply now, and let's make a difference together.