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- Tasks: Lead a team to navigate regulatory requirements and enhance market access for innovative medical products.
- Company: Join Thermo Fisher Scientific, a leader in science and inclusivity.
- Benefits: Competitive salary, career growth, and a supportive workplace culture.
- Other info: Collaborate with diverse teams and engage with healthcare providers globally.
- Why this job: Make a real impact on global health while advancing your career in a dynamic environment.
- Qualifications: Experience in regulatory affairs and strong leadership skills required.
The predicted salary is between 36000 - 60000 £ per year.
Joining Thermo Fisher Scientific means engaging in meaningful work that positively affects the world. Our colleagues bring our Mission to life daily, helping customers create a healthier, cleaner, and safer planet. We equip our global teams with resources to reach personal career objectives while advancing science through solutions addressing challenges like environmental protection, food safety, and cancer research.
Position Summary
The purpose of this role is to increase market access for Microbiology Division’s (MBD) clinical IVD products through successful pre-market licenses, renewals, and strategic market analysis. This position focuses on navigating regulatory requirements to enable global market entry through licensing and regulatory strategy. The role leads a team of nine regulatory professionals who craft submissions based on product technical data and capture vital regulatory intelligence. Key interfaces include the Global Regulatory Affairs team, Marketing, Sales, and Thermo Fisher regional RA shared services.
Responsibilities
- Regulatory Licensing and Compliance: Acquire pre-market licenses, handle renewals, and maintain license changes globally. Ensure regulatory pathways, documentation, and country-specific requirements are accurately interpreted and implemented.
- Market Access Strategy and Analysis: Perform market assessments to aid regulatory pathways and worldwide market introduction.
- Regulatory Intelligence: Acquire, assess, and communicate actionable regulatory intelligence across global teams.
- Operational Excellence: Develop and monitor key performance indicators related to licensing activities. Drive continuous improvement initiatives to reduce time‑to‑license, improve submission quality, and optimize global processes.
- External Engagement: Engage with healthcare providers and regulatory authorities to support submission discussions, clarify regulatory expectations and answer questions.
- Cross‑Functional Coordination: Collaborate with Regulatory Affairs, Marketing, Sales, Product Management and Quality on market access strategies, product compliance and lifecycle changes.
- Leadership & Team Development: Direct and mentor a team of regulatory professionals by communicating clear objectives, prioritizing tasks, and upholding accountability. Support personal development, professional progression, and a positive workplace culture.
Minimum Qualifications
- Bachelor’s/Master’s Degree or equivalent experience, diploma, or equivalent combination of qualifications in life science, engineering, legal, or related fields.
- Validated experience with international regulatory affairs within the medical device or IVD industry.
- Over 5 years of experience in regulatory affairs, including handling global submissions and market entry.
Skills
- Excellent regulatory communication and presentation skills at all organizational levels.
- Expertise in multinational regulatory strategy, risk‑benefit analysis, and collaboration with internal and external partners.
- Strong project management skills with the ability to manage complex global portfolios and prioritize competing deadlines.
- Ability to develop and engage in a high-performance team dedicated to accountability.
- Capability to lead, influence, and innovate within a cross‑functional environment.
Regulatory Affairs Manager - Market Access employer: myGwork - LGBTQ+ Business Community
Contact Detail:
myGwork - LGBTQ+ Business Community Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Manager - Market Access
✨Tip Number 1
Network like a pro! Reach out to people in the industry, especially those already working at Thermo Fisher Scientific. A friendly chat can open doors and give you insider info that could help you stand out.
✨Tip Number 2
Prepare for interviews by researching the company’s mission and values. Show how your experience aligns with their goals, especially in market access and regulatory affairs. We want to see your passion for making a difference!
✨Tip Number 3
Practice your pitch! Be ready to explain your regulatory experience and how it relates to the role. We love candidates who can clearly communicate their achievements and how they can contribute to our team.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, it shows you’re serious about joining our mission to create a healthier, cleaner, and safer planet.
We think you need these skills to ace Regulatory Affairs Manager - Market Access
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Regulatory Affairs Manager role. Highlight your experience in regulatory affairs, especially in the medical device or IVD industry. We want to see how your skills align with the job description!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about market access and how your background makes you a perfect fit for our team. Keep it engaging and relevant to the role.
Showcase Your Achievements: Don’t just list your responsibilities; showcase your achievements! Use specific examples of how you've successfully navigated regulatory requirements or improved processes in previous roles. We love seeing results!
Apply Through Our Website: We encourage you to apply through our website for the best chance of getting noticed. It’s straightforward and ensures your application goes directly to us. Plus, we can’t wait to hear from you!
How to prepare for a job interview at myGwork - LGBTQ+ Business Community
✨Know Your Regulatory Stuff
Make sure you brush up on your knowledge of international regulatory affairs, especially in the medical device or IVD industry. Be ready to discuss specific regulations and how they impact market access strategies. This will show that you’re not just familiar with the basics but can navigate complex regulatory landscapes.
✨Showcase Your Leadership Skills
Since this role involves leading a team of regulatory professionals, be prepared to share examples of how you've successfully managed teams in the past. Talk about how you set clear objectives, prioritised tasks, and fostered a positive workplace culture. This will demonstrate your capability to lead and develop high-performance teams.
✨Prepare for Cross-Functional Collaboration
This position requires working closely with various departments like Marketing, Sales, and Quality. Think of examples where you’ve collaborated across functions to achieve a common goal. Highlight your communication skills and how you’ve engaged with different stakeholders to drive successful outcomes.
✨Market Access Strategy Insights
Be ready to discuss your approach to market access strategy and analysis. Prepare to talk about any market assessments you've conducted and how they informed regulatory pathways. Showing that you can think strategically about market entry will set you apart from other candidates.