Regulatory Affairs/Product Steward Specialist

Work Schedule

Environmental Conditions

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 Thermo Fisher Scientific as a Regulatory Affairs Specialist III and contribute to ensuring compliance with global regulations while enabling our mission to make the world healthier, cleaner, and safer. You'll provide strategic regulatory and Product Stewardship guidance and expertise for product development, change management, registration, and lifecycle assessments across Filtration and Separation Division's portfolio. Collaborate with cross-functional teams to develop and implement regulatory strategies that enhance time-to-market while maintaining the highest standards of compliance. Serve as a key liaison with internal stakeholders and external partners to achieve successful outcomes.REQUIREMENTS:

• Bachelor’s degree or higher in a science or engineering discipline plus 5 years of experience in regulatory affairs in the EHS&R, environmental sciences, quality, technical field, pharmaceutical, or medical device

• Preferred Fields of Study: life sciences, chemistry, engineering, pharmacy, or related scientific field

• Strong knowledge of global regulatory requirements and regulatory compliance experience in one or more of the following areas: regional and global article and chemical regulations including but not limited to TSCA, REACH, RoHS; conflict minerals, consumer product safety laws, hazard communication, biocide regulations, global food contact regulations and regulations impacting biopharmaceutical manufacturers such as FDA and USP

• Experience conducting product life cycle assessments or product risk assessments for new product commercialization and existing product changes

• Demonstrated success in regulatory strategy development and implementation

• Understanding of quality systems including ISO 9001 and ISO 134875 and risk management principles

• Demonstrated risk-based decision-making skills

• Excellent project management skills with ability to manage multiple projects simultaneously

• Strong analytical and problem-solving capabilities

• Clear written and verbal communication skills

• Experience working effectively in cross-functional team environments

• Fluency in English required; additional languages beneficial

• Proficiency with Microsoft Office suite

• Strong attention to detail and organizational skills

• Ability to interpret and apply complex regulatory requirements

• Customer-focused mindset with business acumen

• Available for occasional travel (10-20%)

• Effective interpersonal skills and ability to build consensus

Compensation and Benefits

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs

• Employee assistance and family support programs, including commuter benefits and tuition reimbursement

• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards