Regulatory Affairs Specialist II (IVD/Medical Devices)

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.

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;

• Responsible for sanitary compliance at the municipal and federal levels for legal entities;

• Responsible for compliance of companies with professional councils (CRF, CRMV, CREA, etc);

• Evaluate and contribute to merger/acquisition/closure processes by assessing regulatory impact and product registration;

• Ensure that health regulations are met locally and by headquarters through the establishment of procedures, structured communication, and document management;

• Prepare, submit, and monitor processes to obtain product registration (new, amendments, additions, cancellations) with ANVISA for the group's various divisions;

• Perform follow-up on product registrations submitted to ANVISA, complying with current health regulations;

• Provide regulatory support to logistics, commercial, marketing, logistics operator, and customs broker areas;

• Ensure that the following documents are current and in accordance with applicable health regulations: CMVS, AFE, CRF, CRBio, Letters of Authorization (LoA), GMP Certificates, Powers of Attorney, and Letters of Exclusivity.