Regulatory Affairs Manager

Regulatory Affairs Specialist III

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. You'll provide strategic regulatory guidance and expertise for product development, registration, and lifecycle management across our diverse portfolio. Collaborate with cross-functional teams to develop and implement regulatory strategies that enhance time-to-market while maintaining the highest standards of compliance. Serve as a key liaison with regulatory authorities, internal stakeholders, and external partners to achieve successful outcomes.

Requirements:

• Clear prioritization in accordance to business needs (governance boards)
• Develop regulatory strategies aimed at achieving marketing authorization, regulatory compliant product labeling, and change notifications
• Independently prepare and execute regulatory assessments of change requests
• Independently establish, compile and submit documents in accordance with regulatory requirements aimed at achieving or maintaining marketing authorization
• Issue release statements for limited and for legal releases to Phadia AB
• Active lead and expert in product registration projects on defined global markets
• Communicate with internal and external partners as well as authorities including troubleshooting and removing barriers to execution
• Participate in the vigilance process; monitor, assess and communicate regulatory requirements, regulations and guidelines in your area of expertise / global markets
• Establish work procedures, instructions and templates within your area of expertise
• Develop effective regulatory workflows and identify critical pathways with stakeholders and authorities
• Contribute to improved routines and processes for the Global Regulatory Affairs team
• Plan, lead, distribute and track activities within your regulatory specialist box
• Train and update the RA team and colleagues in IDD on your activities and area of expertise as required
• Proactively provide regulatory requirements and communicate clear regulatory strategies; utilize the regulatory strategy template
• Issue, review and approval of product documentation and labeling
• Participate in product development as regulatory expert
• Fluent in English, both spoken and written is a must
• University degree in natural, pharmaceutical or technical science; 5+ years of experience within the regulated pharmaceutical, life science, MD or IVD industries and knowledge of relevant standards (e.g. ISO 13485, ISO 23640, ISO 14971, ISO 18113, ISO 15223)
• 6+ years of profound regulatory experience working with authorities worldwide and a thorough understanding of international regulations
• Strong leadership, including meeting management, presentation skills and coaching
• Results driven and team-oriented with the ability to influence outcomes as necessary
• Excellent organizational and time management skills required to manage multiple ongoing business activities simultaneously
• Excellent communication skills. Ability to communicate orally, in written documents, and in formal presentations is required
• Awareness of and sensitivity to cultural diversities
• Practical AI literacy, including the ability to use AI-enabled tools responsibly to improve efficiency, support analysis, and enhance the quality of deliverables.