Sr Manager, Regulatory Affairs

at  Thermo Fisher Scientific

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.

LOCATION/DIVISION SPECIFIC INFORMATION

Thermo Fisher is seeking a Regulatory Affairs professional to join the area of molecular diagnostics to lead the Bio-Sciences Division Regulatory Affairs team in North America!

EDUCATION:

• Bachelor degree in Biology, Chemistry, bio-engineering, or related science required.

EXPERIENCE:

• Minimum of 7-10 years Regulatory Affairs experience in Pharmaceutical, Biologics, In vitro diagnostics, or Medical Devices. This experience must include either BLA, 510(k), PMA, CE IVD submissions.
• Well versed in the aspects of regulatory strategy creation, design control, cGMP/quality systems, and import/export requirements.
• Experience as the RA representative on project core teams providing regulatory guidance and RA strategies.
• Managerial competencies in leading impactful teams, demonstrating strong decision-making skills, and the ability to prioritize and deliver on multiple projects simultaneously.

KNOWLEDGE, SKILLS, ABILITIES:

• High energy level; positive attitude; works well under stress, Strong communicator and leader. Hands-on, willing to take action, and able to implement effectively through their team.
• Continuous improvement minded; familiar with balancing the need for Quality and the need for efficiency.
• Ability to provide solutions based on knowledge of regulation and experience.
• Willingness to travel (~10-15%).

Please refer the Job description for details