2 дня назад
Associate Director, Regulatory Legal Counsel (MedTech)
110 600 - 166 000GBP
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Associate Director, Regulatory Legal Counsel (MedTech): Providing strategic legal guidance across the lifecycle of medical devices, diagnostics, and life science products in EMEA and Latin America with an accent on EU and UK regulatory frameworks, product commercialization, and post-market obligations. Focus on interpreting multi-jurisdictional requirements, advising on AI-related regulation, supporting inspections and recalls, and coordinating regulatory interactions with authorities and external counsel.
Location: Cambridge, England, UK; hybrid. The London/Cambridge area is preferred, and limited regional and international travel may be required. The role is not eligible for visa sponsorship.
Salary: GBP 110,600–166,000 per year, plus eligibility for variable cash compensation and, where applicable, equity.
Company
develops genomic technology supporting early disease detection, diagnosis, treatment options, and greater health equity.
What you will do
- Provide regulatory legal guidance for medical devices, diagnostics, and life science products across EMEA and Latin America.
- Interpret EU and UK medical device and IVD frameworks, country-specific requirements, and related sector regulations.
- Support product development, regulatory submissions, market access, product lifecycle management, and post-market obligations.
- Advise on hardware, software, services, digital solutions, and AI-related regulatory requirements.
- Review labeling, marketing materials, communications, contracts, tenders, licensing, distribution, R&D, and procurement activities.
- Support inspections, audits, recalls, field actions, regulatory authority interactions, training, policies, SOPs, and engagement with external counsel.
Requirements
- Qualified lawyer in the UK, the United States, or an EU Member State.
- Significant regulatory advisory experience in medical devices, medtech, biotechnology, or life sciences.
- Experience advising business clients in a regulated, international environment.
- Full professional fluency in English.
- Ability to work across time zones in a global organization.
- Visa sponsorship is not available for this role.
Nice to have
- Experience with EU and UK medical device and diagnostics frameworks, including IVDR.
- Experience with post-market vigilance, inspections, and regulatory authority interactions.
- Experience supporting global or regional product development and lifecycle management.
- In-house and/or law firm experience advising regulatory clients.
- Additional language skills.
Culture & Benefits
- Flexible time off, private medical insurance, compassion and care time off, and leisure travel insurance.
- UK pension contribution of 10%, flexible benefits, and an employee stock purchasing program.
- Volunteer time off and a weeklong company-wide summer shutdown.
- Inclusive environment with employee resource groups supporting career development, cultural awareness, and social responsibility.
- Collaborative work with regulatory, quality, medical, commercial, compliance, and other cross-functional teams.
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