Regulatory Affairs Specialist III

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Loud Noises (Equipment/Machinery), Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Warehouse, Will work with hazardous/toxic materials

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.

Pharma Services Group (PSG) is a global leader in providing integrated services across all phases of drug development and manufacturing. We offer a unique breadth of capabilities, from drug development and clinical trial logistics to commercial manufacturing and packaging. Our end-to-end solutions help pharmaceutical and biotech companies of all sizes bring new medicines to patients faster.

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 guidance and expertise for product development, registration, and lifecycle management across our diverse 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 regulatory authorities, internal stakeholders, and external partners to achieve successful outcomes.

REQUIREMENTS:

• Advanced Degree plus 3 years of experience, or Bachelor's Degree plus 5 years of experience in regulatory affairs in the pharmaceutical, medical device, or similar industry.
• Preferred Fields of Study: life sciences, chemistry, engineering, pharmacy, or related scientific field
• Additional certifications like RAC (Regulatory Affairs Certification) advantageous
• Strong knowledge of global regulatory requirements, particularly FDA, EU MDR/IVDR, and other major markets' regulations
• Experience preparing and submitting regulatory filings (e.g., 510(k), CE marking, technical files)
• Demonstrated success in regulatory strategy development and implementation
• Expert understanding of quality systems (ISO 13485, GMP/QSR) and risk management principles
• 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 regulatory submissions software and Microsoft Office suite
• Experience with change control and post-market surveillance activities
• Strong attention to detail and organizational skills
• Ability to interpret and apply complex regulatory requirements
• Customer-focused mindset with business acumen
• Effective interpersonal skills and ability to build consensus
• Experience supporting regulatory staff development preferred

---

OTHER

• Relocation assistance is not provided.
• Must be legally authorized to work in the United States now and in the future, without sponsorship.
• Must be able to pass a comprehensive background check, which includes a drug screening.