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.
Join our team at Thermo Fisher Scientific as a Regulatory Affairs Specialist II, where you'll ensure product compliance and market access for our innovative diagnostic solutions. You'll work with cross-functional teams to manage regulatory submissions, maintain product registrations, and support quality management systems across global markets. This position offers excellent opportunities for professional growth while contributing to our mission of enabling customers to make the world healthier, cleaner, and safer.
REQUIREMENTS:
- Bachelor's Degree plus 2 years of experience in regulatory affairs, preferably in IVD/medical device industry
- Preferred Fields of Study: Life Sciences, Pharmacy, Biology or related scientific field
- Strong knowledge of regional regulations (ANVISA) (ANATEL-desirable)
- Experience preparing and reviewing technical documentation and regulatory submissions
- Excellent organizational skills
- Superior written and verbal communication skills
- Intermediate English and basic Spanish required;
- Detail-oriented with strong documentation skills;
- Demonstrated ability to manage multiple priorities and meet deadlines;