Quality Assurance & Regulatory Affairs Specialist
London | Clinical & Scientific Operations About Pangaea Data Limited
Pangaea Data (Pangaea) is a South San Francisco and London based business founded by Dr Vibhor Gupta and Prof Yike Guo (Director Data Science Institute at Imperial College London; Provost, Hong Kong University of Science and Technology). They have worked in medicine and computing for over 20 years and have raised over $300 million through their academic research, including a $110 million grant focused on development work on large language models in medicine. Pangaea’s AI platform is configured on clinical guidelines to find more untreated (undiagnosed, miscoded, at-risk) and under-treated patients with hard-to-diagnose conditions for screening and treatment at the point of care. Pangaea’s advisors include industry veterans from healthcare and the life sciences, including Lord David Prior (former chairman, NHS England) and Mr. Andy Palmer (former CIO, Novartis). The Role
As the Quality Assurance & Regulatory Affairs Specialist you will be responsible for building and leading the company’s regulatory and quality foundation from the ground up. In this role, you will be expected to develop and implement a scalable QMS, prepare relevant projects for global regulatory submissions, and drive a culture of quality across the organization. Key Responsibilities
Develop and Implement Regulatory & Quality Strategy:
Personal Traits
Empathetic understanding of user and stakeholder needs, especially across varying stages of product maturity and regulatory environments.
Excellent communication and mediation skills, with the ability to convey complex regulatory and quality concepts to both technical and non-technical stakeholders.
Collaborative team player who thrives in cross-functional environments involving engineering, clinical, marketing, and executive stakeholders. Must Haves:
Please submit your CV and coverletter outlining your relevant experience in Quality Assurance & Regulatory Affairs to View email address on meeveem.com. General Information
Pangaea Data is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, colour, sex, sexual orientation, gender identity or expression, religion, national origin or ancestry, age, disability, marital status, pregnancy, protected veteran status, protected genetic information, political affiliation, or any other characteristics protected by local laws, regulations, or ordinances.
London | Clinical & Scientific Operations About Pangaea Data Limited
Pangaea Data (Pangaea) is a South San Francisco and London based business founded by Dr Vibhor Gupta and Prof Yike Guo (Director Data Science Institute at Imperial College London; Provost, Hong Kong University of Science and Technology). They have worked in medicine and computing for over 20 years and have raised over $300 million through their academic research, including a $110 million grant focused on development work on large language models in medicine. Pangaea’s AI platform is configured on clinical guidelines to find more untreated (undiagnosed, miscoded, at-risk) and under-treated patients with hard-to-diagnose conditions for screening and treatment at the point of care. Pangaea’s advisors include industry veterans from healthcare and the life sciences, including Lord David Prior (former chairman, NHS England) and Mr. Andy Palmer (former CIO, Novartis). The Role
As the Quality Assurance & Regulatory Affairs Specialist you will be responsible for building and leading the company’s regulatory and quality foundation from the ground up. In this role, you will be expected to develop and implement a scalable QMS, prepare relevant projects for global regulatory submissions, and drive a culture of quality across the organization. Key Responsibilities
Develop and Implement Regulatory & Quality Strategy:
- Define, develop, and execute regulatory strategy for SaMD approval in key global regions.
- Establish a fit-for-purpose Quality Management System (QMS) aligned with ISO 13485, 21 CFR Part 820, and other relevant standards.
- Prepare, lead, and manage regulatory submissions and communications with authorities.
- Ensure readiness for audits and facilitate inspections from regulatory authorities and certification bodies.
- Lead training initiatives to ensure all relevant teams understand and adhere to QMS and regulatory requirements.
- Develop and maintain standard operating procedures, compliance documentation, and internal audit processes.
- Serve as the internal authority on quality and regulatory matters, advising leadership and project teams.
- Monitor relevant regulatory changes and update internal systems and policies accordingly.
- Work closely with biomedical, clinical, engineering, and marketing teams to embed quality and regulatory considerations into every phase of development.
- Ensure that project timelines and product goals are aligned with regulatory requirements.
- Communicate regulatory risks and solutions to non-regulatory stakeholders.
Personal Traits
Empathetic understanding of user and stakeholder needs, especially across varying stages of product maturity and regulatory environments.
Excellent communication and mediation skills, with the ability to convey complex regulatory and quality concepts to both technical and non-technical stakeholders.
Collaborative team player who thrives in cross-functional environments involving engineering, clinical, marketing, and executive stakeholders. Must Haves:
- Demonstrated experience in quality assurance and/or regulatory affairs in the medical device, diagnostics, or digital health industry.
- Track record of hands-on experience with regulatory submissions and interactions with authorities in at least one major jurisdiction.
- Strong working knowledge of ISO 13485, ISO 14971, IEC 62304, and other relevant SaMD standards.
- Experience preparing for and supporting audits and inspections by regulatory bodies or notified bodies.
- Demonstrated success in leading or implementing a QMS.
- Direct experience with SaMD regulatory pathways
- Experience working within a MedTech or health tech company, preferably in a fast-paced or startup environment
- Experience navigating multi-region regulatory strategies
- Familiarity with cybersecurity, privacy, and clinical evaluation requirements for digital health products
- Experience working in or for a company that achieved first-time regulatory approval
- Flexible working hours.
- Salary dependent on experience.
- Benefits include private medical insurance, life insurance and travel cards.
- You would join a small, dedicated and fast-growing team.
- You will have the opportunity to learn about building a startup business from experienced professionals and serial entrepreneurs.
- We are currently supported by serial entrepreneurs and angel investors. You will have the opportunity to experience an investment life cycle for a startup and meet leading venture capitalists.
Please submit your CV and coverletter outlining your relevant experience in Quality Assurance & Regulatory Affairs to View email address on meeveem.com. General Information
Pangaea Data is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, colour, sex, sexual orientation, gender identity or expression, religion, national origin or ancestry, age, disability, marital status, pregnancy, protected veteran status, protected genetic information, political affiliation, or any other characteristics protected by local laws, regulations, or ordinances.
Vacancy posted 5 days ago
Similar jobs that could be interesting for youBased on the Quality Assurance & Regulatory Affairs Specialist in London vacancy
£36 - £40 per hour
...We are currently looking for an experienced Quality Assurance and Standards Officer to support a Housing Service in maintaining regulatory compliance, improving service standards and preparing for regulatory inspections. This Quality Assurance and Standards Officer role will...SuggestedFull-time£27.81 - £40 per hour
...Quality Assurance & Standards Officer needed in North London Paying £27.81 per hr ref 000B 12D8 / 1 Full time hours on a temporary basis Key Responsibilities Undertake reconciliation of affordable rent agreements and confirm GLA approvals for all affordable rent units...SuggestedFull-timeTemporary£25.06 per hour
Job Category : Environmental Services Location : 160 Tooley Street, Southwark Council Hours Per Week : 36.00 Start Date : Immediate Start Start Time :09:00 End Time : 17:00 Salary: £25.06 36 hours per week, min 2/3 days in office at Tooley Street. Must have ...SuggestedFull-timeOn-siteImmediate startWeekend workAfternoon shift- £39k - £51k per annumEstimatedHelp Build Europe's Hypersonic Capability At Hypersonica , we’re redefining what’s possible in European defence technology. We exist to deliver speed, resilience, and technological independence at a pace that sets a new standard. We are a small, elite team working on...SuggestedFull-time
£100.24k - £186.16k per annum
...Responsible AI practices across Development, ensuring that all AI solutions adhere to internal policies, ethical standards, and external regulatory requirements. The role operationalizes governance across the full AI lifecycle, translating Responsible AI principles into clear,...SuggestedHybrid workingFlexible hours- £77k - £102k per annumEstimated...retrofitted later Create and maintain lean, effective policies and documentation that are actually used by the team Stay on top of regulatory changes and translate them into simple, actionable steps for the business Act as an internal advisor, helping the team understand...Full-timeHybrid workingOn-siteRemote
£22k per annum
...Wayman Education is a specialist recruitment agency with over 20 years experience within the education field. We’ve worked hard to establish our reputation with our clients as one of the most reliable teaching agencies in London through our core values of honesty and customer...On-siteImmediate startProbationary period£65k per annum
We’re seeking a proactive and ambitious Compliance professional to join a growing insurance broking business. This is an excellent opportunity for someone with compliance administration experience (e.g. onboarding, KYC, TOBA management) or broader compliance exposure looking...- £51k - £67k per annumEstimated...Oversight Officer to provide second line of defence (2LoD) oversight over 1LoD (first line of defence) teams, so that they meet their regulatory obligations and effectively manage their regulatory compliance and conduct risks. Please note; this role is a 12 month fixed term...16 hoursFull-timeFixed-term contract
£76k - £114k per annum
...includes acting as SMF 16 ensuring adherence to applicable UK regulatory requirements and industry standards. The role reflects... ...consultations, filings, and supervisory interactions Provide assurance to management regarding the business' implementation of Compliance...Full-timeHybrid workingOn-site£10k per annum
...information governance (IG), data protection, and regulatory compliance across CF. It is also an... ...readiness, and providing structured assurance to the Board and Executive Committee. Responsibilities... ...Security Management) and ISO 9000 (Quality Management) audit programmes including:...Long-term contractFull-timeHybrid workingOn-siteRemoteWork from homeFlexible hours- £55k - £72k per annumEstimated...Purpose of Position The eCommerce Compliance & Fraud Specialist (internal job title: Senior Network Quality Intelligence Specialist) plays a critical role in safeguarding the integrity, trust, and commercial viability of the Awin network. This role goes beyond standard investigation...Hybrid workingOn-siteRemote
- £74k - £95k per annumEstimated...implementation of new surveillance initiatives; Carry out quality assurance of surveillance alerts that are undertaken by level 1... ...Maintain a detailed working knowledge of key EU /UK regulatory rules and regulations as well as a broad awareness of specific...Long-term contractTemporarySkilled worker visa
- £57k - £77k per annumEstimated...Financial Crime team is at the core of that journey. As a Senior Compliance Officer you will strengthen our second-line function, bringing regulatory product oversight to ensure compliance robustness while enabling growth. You will collaborate closely across first-line Operations,...Full-time
£50k per annum
...employee conduct controls (e.g. PA dealing, conflicts of interest, gifts & hospitality) Maintaining compliance logs, registers, and records Supporting regulatory reporting and filings Assisting with policy and procedure updates in line with regulatory developments...Fixed-term contractInterim- £52k - £68k per annumEstimatedRegulatory Consultant - CMC (CMC with small molecule products) Syneos Health® is a leading fully-integrated life sciences services organization... ..., with a preference in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another related life...
- £53k - £69k per annumEstimated...in administration, accounting, reporting, regulatory and compliance needs of the investment... ...will play a key role in delivering high-quality compliance consulting services to a diverse... ...as private health and dental cover, life assurance, discounted gym membership, eye test and...Long-term contractFull-timeHybrid workingFlexible hours
£76k - £114k per annum
...London, working collaboratively to monitor emerging risks and regulatory developments across all jurisdictions where Swiss Re operates.... ...These would be a plus: Certified Global Sanctions Specialist (CGSS) or another professional sanctions certification Knowledge...Full-timeHybrid workingOn-site- £61k - £81k per annumEstimated...Job Description The team works closely with the International Consumer Business to contribute in shaping the evolving financial regulatory landscape across the UK and EU. As an Associate within the Regulatory Policy function , you will support the ICB across all...Long-term contract
- £43k - £57k per annumEstimated...ho We’re Looking For We’re looking for a Compliance Officer to support Incard’s client onboarding, financial crime controls, and regulatory operations. You’ll work closely with the Compliance, Risk, and Operations teams to ensure customers are onboarded safely, monitored...Full-time
£35k - £40k per annum
...compliance performance, track operational data, and produce high-quality management information (MI) ahead of strict deadlines. Risk &... ...policies that align with global company standards. Quality Assurance (ISO): Undertake independent audits to flag risks, manage non-compliance...40 hours/weekPermanentFull-timeWork from homeMonday to Friday- ...highest standards of data protection, legal compliance, and information governance. This is a pivotal role for an individual with strong regulatory knowledge and a practical approach to managing legal risk, ensuring compliance with legislation such as UK GDPR, the Data Protection...Part-timeFlexible hours
- £54k - £72k per annumEstimated...belonging. Join us on our One Perrigo journey as we evolve to win in self-care. As a member of the Europe North Cluster Regulatory Affairs Team, the Senior Regulatory Affairs Associate will focus on post marketing regulatory activities for medicinal products within...Fixed-term contractHybrid workingRemote2 days/week
£90k - £110k per annum
1. Regulatory Monitoring & Interpretation Track changes to applicable UK and international regulations (e.g., FCA, PRA, GDPR, AML) and translate them into practical guidance for business stakeholders.2. Policy Development & Governance Draft, update, and maintain internal...Permanent£30k - £35k per annum
...strong interest in pursuing a career in compliance, to join a boutique London law firm. The role offers exposure to a broad range of regulatory, policy and onboarding work, with clear scope for long-term progression in a supportive and collaborative environment. Key...Long-term contractPermanentFixed-term contractOn-site£120k - £150k per annum
The Compliance Officer - SMF16 will be responsible for leading the Retail Investments arm of the UK business.You will work closely within the global compliance function and there will be opportunities to work closely with senior members of the Compliance team globallyPermanent- £53k - £70k per annumEstimated...dedicated and motivated Sr. Compliance Specialist, EMEA, reporting to the Director, Compliance... ...with business functions (e.g., Medical Affairs, Market Access, Marketing) to provide... ...engagements in line with industry codes and regulatory requirements. Knowledge of laws and...Full-timeHybrid workingOn-site
€30k - €48k per annum
...client is a premier, high-growth international Forex brokerage with a rapidly expanding global presence. Committed to transparency, regulatory excellence, and superior client service, they are seeking a skilled Compliance Officer to strengthen their compliance and AML functions...Remote jobULTRA Recruitment
London6 days ago£23.67 per hour
...comprehensive instruction manuals/procedures on all aspects of the work. 12 Awareness of the impact of service development, quality and knowledge management in a customer service environment, evidenced by employing excellent customer service skills and promoting an...Full-timeHybrid workingOn-siteImmediate startMonday to FridayFlexible hours£95k per annum
Governance Risk and Compliance Lea Role: Governance Risk and Compliance Lead Salary: Up to £95,000 + bonus + package Location: London (Hybrid) Essential Skills: • Strong GRC background. • Governance , Risk and Compliance background. • Experience in...PermanentHybrid workingImmediate start
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Quality Assurance & Regulatory Affairs Specialist. Be the first to apply!
Related searches
- qa specialist London
- quality assurance officer London
- quality assurance associate London
- regulatory compliance associate London
- risk and compliance analyst London
- regulatory affairs specialist medical devices London
- risk and compliance officer London
- compliance officer London
- regulatory affairs associate director London
- corporate compliance analyst London