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- Tasks: Lead regulatory compliance for medical devices and chemicals across Europe.
- Company: Join Thermo Fisher Scientific, a leader in life-changing therapies and clinical research.
- Benefits: Enjoy competitive pay, bonuses, healthcare, and a vibrant company culture.
- Why this job: Make a global impact while developing your career in a supportive environment.
- Qualifications: Bachelor’s degree in Life Sciences, Chemistry, or Engineering; senior regulatory experience required.
- Other info: Be part of a forward-thinking team dedicated to health and safety.
The predicted salary is between 43200 - 72000 £ per year.
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life – To enable our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. Alongside clinical research through our PPD clinical research portfolio, our work in accelerated enrollment solutions optimizes each step of the patient journey in clinical trials, such as securing sites and recruiting patients, allowing for more patients to participate in clinical research. Your determination to put patients at the heart of every decision will improve health outcomes that people and communities depend on – now and in the future.
Join Thermo Fisher Scientific as the Senior Manager of Regulatory Affairs and take charge of ensuring Regulatory Compliance across Europe. This pivotal role involves coordinating various products, including medical devices, chemicals, and in-vitro diagnostics.
As a senior leader, you will craft and implement regulatory policies, ensuring compliance with European regulations. You will also lead projects to drive business growth and minimize regulatory risks.
Discover Impactful Work
A day in the Life:
- Develop and implement regulatory strategies for the European market, ensuring compliance with EU regulations for medical devices, pharmaceuticals, chemicals, and in-vitro diagnostics (IVDR).
- Offer strategic mentorship on regulatory matters and align regulatory strategies with corporate objectives.
- Ensure that all government-issued licenses and European and local accreditations are maintained and up to date across all operations.
- Develop and implement regulatory policies and procedures in compliance with European regulations.
- Identify and assess regulatory risks associated with European and global chemical regulations.
- Lead the preparation and compilation of regulatory submissions and annual government reporting.
- Coordinate approvals for new product introductions, including IVDR-regulated in-vitro diagnostic products.
- Act as the main point of contact for European regulatory agencies, the Thermo Fisher Corporate office, and internal collaborators.
- Stay updated on new and evolving European regulatory guidelines and policies.
- Support and lead preparation for internal and external audits.
Desired Profile
- Established proficiency in leading Regulatory Affairs at a senior level, including handling complex projects and cross-functional teams.
- Extensive knowledge of European regulatory requirements for medical devices, chemicals, and in-vitro diagnostics (IVDR).
- Excellent interpersonal skills to engage with European Regulatory authorities, internal teams, and external partners.
- Extensive global regulatory affairs experience, including expertise in European and international chemical regulations, IVDR compliance, and directives like REACH and CLP.
Education
- A Bachelor’s degree or equivalent experience in a field such as Life Sciences, Chemistry, or Engineering.
- Equivalent combinations of education and experience will be considered, with a focus on regulatory project management and compliance expertise.
Experience
- Proven experience in Regulatory Affairs, particularly in Europe, with a strong background in leading chemical regulations and IVDR compliance.
- Experience in leadership of cross-functional regulatory projects and implementation of global regulatory strategies.
Benefits
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
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Senior Manager, Regulatory Affairs employer: Thermo Fisher Scientific Inc.
Contact Detail:
Thermo Fisher Scientific Inc. Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Manager, Regulatory Affairs
✨Tip Number 1
Network with professionals in the regulatory affairs field, especially those who have experience with European regulations. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends and challenges in regulatory compliance.
✨Tip Number 2
Familiarise yourself with the specific regulatory frameworks relevant to Thermo Fisher Scientific's products, such as IVDR and REACH. This knowledge will not only help you understand the role better but also demonstrate your commitment and expertise during interviews.
✨Tip Number 3
Prepare to discuss your leadership experiences in managing cross-functional teams and complex projects. Highlight specific examples where you successfully navigated regulatory challenges, as this will showcase your ability to lead in a senior role.
✨Tip Number 4
Stay updated on recent changes in European regulatory policies and guidelines. Being knowledgeable about current events in the regulatory landscape will position you as a proactive candidate who is ready to tackle the challenges of the role.
We think you need these skills to ace Senior Manager, Regulatory Affairs
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your extensive experience in Regulatory Affairs, particularly in Europe. Emphasise your knowledge of European regulations for medical devices, chemicals, and IVDR compliance.
Craft a Compelling Cover Letter: Write a cover letter that showcases your leadership skills and your ability to handle complex projects. Mention specific examples of how you've successfully implemented regulatory strategies in the past.
Highlight Relevant Experience: In your application, focus on your proven experience in leading cross-functional teams and managing regulatory projects. Include any relevant certifications or training that demonstrate your expertise in this field.
Showcase Interpersonal Skills: Since the role requires excellent interpersonal skills, provide examples of how you've effectively engaged with regulatory authorities and internal teams. This will help demonstrate your ability to communicate and collaborate effectively.
How to prepare for a job interview at Thermo Fisher Scientific Inc.
✨Know Your Regulations
Familiarise yourself with the latest European regulatory requirements for medical devices, chemicals, and in-vitro diagnostics. Being able to discuss specific regulations like IVDR, REACH, and CLP will demonstrate your expertise and readiness for the role.
✨Showcase Leadership Experience
Prepare examples of your past leadership roles in Regulatory Affairs, particularly those involving cross-functional teams. Highlight how you managed complex projects and drove compliance strategies that aligned with corporate objectives.
✨Engage with Interpersonal Skills
Since this role involves liaising with regulatory authorities and internal teams, practice articulating your thoughts clearly and confidently. Be ready to discuss how you've successfully built relationships with stakeholders in previous positions.
✨Stay Updated on Industry Trends
Demonstrate your commitment to continuous learning by discussing recent changes in European regulatory guidelines. Showing that you are proactive about staying informed will impress interviewers and reflect your dedication to the field.
