Regulatory Affairs Manager (Transplant Diagnostics)

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:
As a Regulatory Affairs Manager you'll provide strategic guidance on regulatory pathways, manage submissions, and serve as a subject matter expert on various regulations across multiple jurisdictions. Working closely with cross-functional teams, you'll help develop and implement regulatory strategies that enable the successful commercialization of our advanced products, from initial planning through post-market activities. This position offers excellent opportunities for growth while contributing to our mission of enabling customers to make the world healthier, cleaner, and safer.

REQUIREMENTS:
• Bachelor's Degree plus 5 years of experience in regulatory affairs in IVD/medical device industry
• Preferred Fields of Study: Biology, Chemistry, Bioengineering, or related scientific field
• Demonstrated expertise in global regulatory requirements (FDA, EU MDR/IVDR, TGA, PMDA, MFDS and other international agencies)
• Experience preparing and managing regulatory submissions (510(k), PMA, CE marking, technical documentation)
• Strong knowledge of quality management systems (ISO 13485, GMP, QSR)
• Demonstrated success in regulatory strategy development and implementation
• Experience leading regulatory aspects of product development teams

Knowledge, Skills, Abilities
• Excellent project management and organizational skills
• Strong analytical and problem-solving abilities
• Outstanding written and verbal communication skills
• Ability to interpret and communicate complex regulatory requirements
• Experience with risk management and post-market surveillance activities
• Proficiency in reviewing technical documentation and product labeling
• Ability to work effectively in a matrix organization
• Strong interpersonal skills and ability to build consensus
• Willingness to travel (10-15% typically)
• Ability to adapt to evolving regulatory landscape
• Proficiency with standard office software and regulatory documentation systems

Must be legally authorized to work in the United States without sponsorship. 
Must be able to pass a comprehensive background check, which includes a drug screening.