About the role

Aplyr's Quick Take

This role is for a Regulatory Affairs Manager who will oversee compliance and strategy for medical devices and diagnostics. You'll work with various teams to ensure products meet regulatory standards and facilitate their market entry. It's a managerial position that requires significant experience in regulatory affairs.

Good fit

Ideal candidates have at least 6 years of experience in regulatory affairs within the medical device or pharmaceutical sectors, preferably with an advanced degree. Strong leadership skills and the ability to collaborate across teams are essential.

Worth noting

The role involves interaction with global health authorities and requires travel of 10-20%. The emphasis on both strategic oversight and hands-on regulatory submission work may appeal to those who enjoy a mix of leadership and detailed compliance tasks.

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

DESCRIPTION:
Join our collaborative team at Thermo Fisher Scientific as a Regulatory Affairs Manager, where you'll make a meaningful impact on global healthcare. You'll guide strategic regulatory initiatives for our innovative medical devices, in-vitro diagnostics, and clinical research services. Working closely with cross-functional teams, you'll ensure regulatory compliance while supporting product development and market access. This role offers the opportunity to shape regulatory strategy, interact with global health authorities, and drive excellence in submission quality across multiple jurisdictions.

REQUIREMENTS:
• Advanced Degree plus 6 years of experience, or Bachelor's Degree plus 8 years of experience in regulatory affairs in medical device, IVD, or pharmaceutical industries
• Preferred Fields of Study: Life Sciences, Chemistry, Biology, Pharmacy or related scientific field
• Professional certifications in Regulatory Affairs (RAC) beneficial
• Comprehensive knowledge of global regulations including FDA, EU MDR/IVDR, ICH guidelines
• Expert understanding of regulatory submission requirements (510(k), CE marking, technical files)
• Strong experience managing regulatory submissions and agency interactions
• Advanced project management and organizational skills
• Demonstrated leadership ability and experience managing regulatory teams
• Strong written and verbal communication skills
• Excellent interpersonal skills for cross-functional collaboration
• Strong analytical and problem-solving capabilities
• Proficiency with regulatory submission tools and documentation systems
• Experience with quality management systems and GMP requirements
• Knowledge of clinical trial regulations and requirements
• Ability to interpret and implement new regulatory requirements
• Travel required 10-20%
• Fluency in English required; additional languages beneficial

Skills & Tags

Aplyr's read

Thermo Fisher Scientific is a powerhouse in biotechnology, attracting professionals passionate about advancing scientific research and innovation across diverse roles and regions.
Synthesized from recent postings & public sources

What's promising

•Thermo Fisher is a leader in the biotech industry, offering stability and growth potential.
•The company invests heavily in R&D, fostering innovation and cutting-edge solutions.
•Global presence provides diverse career opportunities across multiple regions and disciplines.

What to watch

•High pressure and fast-paced environment may not suit everyone.
•Complex organizational structure can lead to communication challenges.
•Frequent acquisitions may result in uncertainty and change for employees.

Why Thermo Fisher

•Thermo Fisher's broad product portfolio spans laboratory equipment to clinical diagnostics.
•The company plays a crucial role in global scientific advancements and healthcare solutions.
•Strong focus on sustainability and corporate responsibility sets it apart in the industry.

Aplyr’s read is generated by AI from public sources. Was it useful?

About Thermo Fisher

Thermo Fisher

thermofisher.com

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Thermo Fisher Scientific is a global leader in serving science, providing a range of products and services to help researchers and scientists in laboratories and clinical settings.