Thermo Fisher / PPD
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
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.
DESCRIPTION:
Join our collaborative team as a Regulatory Affairs Specialist I at Thermo Fisher Scientific, where you'll contribute to ensuring our products meet global regulatory requirements and help make the world healthier, cleaner, and safer. You'll work with cross-functional teams to manage product registrations, maintain compliance documentation, and support regulatory submissions across international markets. This position offers excellent professional development opportunities within our innovative environment focused on serving science.
As a valuable member of our Regulatory Affairs team, you'll compile technical documentation, review regulatory requirements, and support product lifecycle management from initial registration through post-market activities. You'll collaborate with Quality Assurance, R&D, Commercial teams, and regulatory authorities to ensure compliance while facilitating efficient product launches and maintaining existing approvals.
Facilitates activities related to Compliance within TechOps team, in close collaboration with Product Quality and External Manufacturing network.
Ensures cross-functional alignment for critical Compliance topics and projects.
Keeps dashboards and compliance operations on track and resolves potential issues that may impact the timely assessment and closure of actions.
The role requires strong sense of ownership, excellent communication and coordination skills in partnership with internal and external partners to ensure accuracy and timely deliverables.
Change Control management:
Deviations management:
Annual Reports:
Health Authority Commitments:
Compliance of Excipients:
REQUIREMENTS:
• Degree in biotechnology, pharmaceutical sciences or bioengineering
• Relevant expertise in CMC Project Management or Quality & Compliance background, or a similar role within the Biotech industry.
• Additional qualifications in Quality Management or Regulatory Affairs advantageous
• Knowledge of medical device and IVD regulations (EU MDR/IVDR, FDA, international requirements)
• Experience with regulatory submissions and documentation management
• Strong technical writing and documentation skills
• Proficiency in Microsoft Office applications (Word, Excel, PowerPoint) and preferably with document management systems
• Excellent organizational abilities and attention to detail
• Strong analytical and problem-solving capabilities
• Effective verbal and written communication skills in English
• Ability to work both independently and collaboratively in a matrix environment
• Experience with regulatory databases and submission systems preferred
• Knowledge of GMP, ISO 13485, and quality management systems
• Ability to manage multiple projects and meet deadlines
• Customer-focused mindset with strong interpersonal skills
• Demonstrates company values of Integrity, Intensity, Innovation, and Involvement
Team player; able to build effective relationships with internal and external stakeholders.
Leadership and communication skills
Experience in operations, planning, project management, and tracking projects with high complexity and risk, including clearly defined critical paths.
Experience managing projects across global locations and time zones, as well as working effectively in diverse cultural and international environments.
Well organized and able to handle multiple assignments in parallel.
Eye for detail and quality conscious attitude.
Proactive – can do mentality.