Senior Regulatory Affairs Associate

At Open Medical, we are a team of dynamic and diverse individuals with one common goal: improving healthcare through digital excellence.

We are digital health experts who created the award-winning Pathpoint clinical workflow platform. Our mission is to help healthcare providers streamline patient pathways and improve collaboration across different care settings through digital transformation. We foster a diverse, inclusive, and development-focused environment where our team can thrive.

Join us in shaping the future of patient care.

We're searching for a Senior Quality and Regulatory Affairs Associate to join our team in Ealing Broadway, London. If you're a highly motivated and ambitious self-starter with a passion for quality management and process improvement, and over two years of experience in the medical device industry, we want to hear from you! This is your chance to play a key role in ensuring our groundbreaking digital health solutions meet the highest standards of safety and compliance.

This is a full-time, office based role in Ealing Broadway, London.

• Quality Management System (QMS) Implementation: Support the development, implementation, and maintenance of the QMS in compliance with ISO 13485 and other relevant regulations (e.g., EU MDR, UK MDR). Assist in creating and updating QMS documentation, including quality manuals, standard operating procedures (SOPs), and work instructions. Champion QMS processes across the company, providing training and support to ensure adherence. Participate in internal and external audits.
• Regulatory Filings and Compliance: Prepare, compile, and submit regulatory documentation for product registrations and approvals in key markets (e.g., UKCA, CE marking). Assist in the creation and maintenance of Technical Files for our software as a medical device (SaMD) products. Monitor changes in the regulatory landscape and assess their impact on the company’s products and processes. Manage post-market surveillance (PMS) and vigilance activities, including incident reporting.
• Cybersecurity and Data Protection: Ensure compliance with medical device cybersecurity regulations and standards (e.g., ISO27001, NHS DTAC). Collaborate with the software development team to integrate security best practices into the product lifecycle. Assist in risk management activities related to information security and data privacy.

• Highly motivated self-starter with a keen interest in quality management and process improvement.
• Excellent written and verbal communication skills including detailed scientific and technical writing.
• Highly organised with the ability to contribute to multiple projects concurrently and contribute to cross-functional projects.
• Ability to understand, assimilate and summarise highly technical and complex scientific content.
• Innovative thinker who is able to take initiative to identify key opportunities and create content independently.
• Takes full ownership of projects from conception to completion, ensuring meticulous attention to detail and delivering high-quality, accurate results.
• Applies a pragmatic, solutions-oriented approach to complex problems, focusing on actionable steps and sustainable improvements to drive project success.

• Education: A bachelor's degree in a relevant scientific, engineering, or life sciences field.
• Experience: 2+ years of experience in a quality assurance or regulatory affairs role within the medical device industry.
• QMS Knowledge: Demonstrable experience working with and implementing a QMS compliant with ISO 13485.
• Regulatory Acumen: Familiarity with medical device regulations such as the EU Medical Device Regulation (MDR 2017/745) and/or UK Medical Devices Regulations and/or FDA.
• SaMD Experience (Highly Desirable): Experience with Software as a Medical Device (SaMD) and related standards is a significant advantage.
• Cybersecurity Awareness (Desirable): An understanding of cybersecurity principles and regulations applicable to medical devices is preferred.

• Holiday: 33 days per year (including National and Bank holidays), which increases with tenure.
• Private Health Insurance by Vitality with a large number of additional benefit and discount schemes including discounted gym membership.
• Cycle to Work scheme.
• Access to a CPD/Learning budget.
• Paid sickness and compassionate leave.
• Enhanced maternity/paternity leave.
• Salary pension scheme.
• Salary range £55,000 - £70,000 per year, depending on experience.

• Apply online via the link in this advert.
• Once we have screened CVs we will reach out for a quick 5–10 minute call to find out a little more about you and confirm logistics.
• The next stage is a 15–20 minute video call with the hiring manager and member of the HR team.
• Our final stage is an in‑person interview, usually with a task to prepare and present back to the panel.
• We strive to keep candidates updated at all stages of the process and respond to all applications.
• We estimate that final stage interviews for this role will take place around the week commencing 10th November or shortly thereafter.

Ealing Broadway, London, United Kingdom.