Regulatory Affairs Specialist

Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team youll 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 worlds toughest challenges like protecting the environment making sure our food is safe or helping find cures for cancer.

DESCRIPTION:

Join our team at Thermo Fisher Scientific as a Regulatory Affairs Specialist II where youll ensure product compliance and support market access for our innovative diagnostic solutions. Youll work with cross-functional teams to manage regulatory submissions maintain product registrations and support quality management system. This position offers excellent opportunities for professional growth while contributing to our mission of enabling customers to make the world healthier cleaner and safer.

• Develop and implement regulatory strategies across projects to ensure that company products are safe compliant and meet applicable regulatory requirements.
• Maintain and continuously improve processes to ensure compliance with relevant regulatory standards and governing authorities.
• Generate and maintain records and documentation for inclusion in Technical Files and global regulatory submissions.
• Support QMS processes related to regulatory responsibilities including Change Control CAPA and related activities.
• Support internal third-party regulatory authority and notified body audits.
• Monitor and maintain global regulatory registration databases.
• Represent the Regulatory Affairs function in cross-functional meetings.
• Liaise with competent authorities and notified bodies to seek guidance and support as needed.
• Provide regulatory guidance and support for Microbiology culture media and other relevant products as appropriate.
• Assist in the preparation and submissions of technical documentation to maintain pre-market licenses globally .
• Conduct regulatory intelligence to assess changes in global regulations and guidance and their potential impact on facility activities.

REQUIREMENTS:

Advanced Degree or Bachelors Degree plus 2 years of experience in regulatory affairs preferably in IVD/medical device industry
Preferred Fields of Study: Life Sciences Chemistry Pharmacy Engineering or related scientific field
Additional regulatory affairs certifications beneficial
Comprehensive knowledge particularly of FDA EU IVDR and MDSAP countries.
Strong understanding of quality management systems (ISO 13485 GMP MDSAP)
Experience preparing and reviewing technical documentation and regulatory submissions
Sound understanding in product lifecycle management and change control processes
Proven ability to interpret and apply regulatory requirements to product development and maintenance
Excellent project management and organizational skills
Strong analytical and problem-solving capabilities
Excellent written and verbal communication skills
Fluency in English required; additional languages beneficial
Proficiency in Microsoft Office and regulatory information management systems
Ability to work effectively in a matrix organization and cross-functional teams
Detail-oriented with strong documentation skills
Demonstrated ability to manage multiple priorities and meet deadlines