Associate Director - Regulatory

Errington Legal; St Albans; Hybrid; GBP 85,000 - 120,000; Full time

Benefits offered by this job

25 days annual leave + bank holidays

Pension plan

Flexible time off

Bonus scheme

Private Medical Insurance

Life Assurance

On-site gym

Job summary

Errington Legal is recruiting a European Regulatory Lead for a global biotech, based in London or Cambridge with hybrid working. The role centers on regulatory and quality matters for medical device products, including RUO and clinical offerings.

You will advise the business on complex regulatory frameworks and collaborate across Reg Affairs, Med Affairs, Marketing, Compliance and Commercial teams to shape submissions and market access strategies.

Qualifications

• Senior regulatory experience in an international setting.
• Strong knowledge of EU/UK medical device regulation and quality systems.
• Ability to provide pragmatic regulatory solutions and risk assessments.

Responsibilities

• Lead regulatory and quality activities for medical device products (RUO and clinical offerings).
• Advise global business units (EMEA) on complex regulatory frameworks.
• Collaborate with Reg Affairs, Med Affairs, Marketing, Compliance and Commercial teams.

Skills

Regulatory affairs leadership

EU/UK medical device regulation

Cross-functional collaboration

Analytical risk assessment

Commercial mindset

Education

UK or EU regulatory qualification

Job description

A regional lead Regulatory role in a global biotech

European Regulatory Lead- London or Cambridgewith hybrid working

If you're looking for an opportunity to work as part of a global teamand utilise a breadth of European regulatory capability in a region-lead role, this could be an excellent opportunity for you with aground-breaking global biotechnology company with a focus on ethical innovation.

Potentially suited to either an experienced in-house practitioner or someone looking for their first role from practice, either individual would find substantial support across an experienced team both locally and throughout the business' global hubs.

Role

• Focusing primarily on regulatory and quality matters of medical technology products, including RUO and clinical offerings
• Advise the business and its teams/functions globally (EMEALA) on complex regulatory frameworks
• Working closely with teams across Reg Affairs, Med Affairs, Marketing, Compliance and Commercial among others
• Supporting regional submissions, market-access strategies and post-market matters
• Evaluating and providing cross-function guidance on regulating changes and industry adaptations

You

• UK or dual UK/EU Qualified
• Senior advisory and commercial experience in a regulatory setting, ideally in an international setting
• Demonstrable life sciences and medical devices regulatory knowledge/experience
• An essential skill will be providing practical solutions from analytical judgement of regulatory risk and/or change
• Multilingual skills an advantage, but not essential
• Pragmatic and commercially focused with excellent interpersonal skills

Benefits include:

• 25 days annual leave plus bank holidays
• Pension plan
• Flexible time off
• Bonus scheme
• Private Medical Insurance
• Life Assurance
• On-site gym

We are an equal opportunities recruiter, committed to ensuring an inclusive and supportive recruitment process. We embrace and promote diversity as we understand the importance and value of this both for us and our clients.