Job Title: Regulatory Affairs Manager, China
When you’re part of the team at Thermo Fisher Scientific, you’ll do important work. Surrounded by collaborative colleagues, you’ll have the support and opportunities that only a global leader can give you. Our respected, growing organization has an exceptional strategy for the near term and beyond. Take your place on our strong team, and help us make significant contributions to the world.
LSG China Regulatory Affairs Manager (based in Shanghai or Beijing) is responsible for managing all aspects of In-Vitro Diagnostic and Medical Device regulatory requirements and deliverables including establishing regulatory strategies, leading product submissions and regulatory compliance activities, and managing tactics for LSG China Regulatory Affairs in line with corporate and divisional objectives.
Essential Functions - Regulatory Affairs:
- Compile and review regulatory submissions, Technical Files, and labelling for completeness and quality.
- Participate in internal company regulatory/quality audits and assist, as needed.
- Identify regulatory requirements for new product and changes to existing products.
- Determine the scope of information/documentation necessary to file new registration applications and post-approval changes to regulatory agencies.
- Keep Regulatory Team and appropriate LSG personnel informed of significant China regulatory issues affecting Life Technologies products.
- This position is the primary regulatory liaison representative on project teams, providing team members with regulatory requirements for regulatory submissions, primarily in the China region, with some international regulatory applications.
- Serves as the primary contact with applicable regulatory agencies.
- Ensure regulatory project deadlines and required performance standards are established and met.
- Working within the LSG Regulatory Affairs organization, provide regulatory and scientific advice to other areas of the LSG Division.
- Develop contacts with distributors, consultants, and regulatory agencies.
- Review new and existing China regulatory guidance documents, and prepare comments on new documents as needed.
- Provide technical support on specific and/or general issues.
- Participate in customer audits, as needed.
- Work with operations and customers to resolve and implement corrective and preventive actions resulting from major technical complaints.
- Participate in appropriate exhibitions and conferences.
- Should be at ease with direct communication with internal teams, management, and external regulatory agencies, distributors and customers.
- Should be organized, able to work to on multiple projects, with tight deadlines.
- High energy level; positive attitude; works well under stress; strong communicator.
- Balance of strategic thinking, analytical skill and ability to execute.
- Hands-on, action-oriented, and able to implement effectively.
- Able to work autonomously in a matrix-managed organization.
- Courageously faces reality and can provide opinions and solutions in face of adversity; decisive and able to provide clear guidance to the organization in the absence of conclusive data, or of clear guidance from the regulators (as is often the case with RA matters). Able to make these decisions without excessive use of consultants.
- Comfortable with ambiguity and change.
- Requires a minimum of 10 years of relevant experience, including business integration and strategy.
- Direct experience in communicating with Regulatory Authorities and Distributors.
- Multi-site experience, in a mid to large size company; experience in building global systems.
- Global/International regulatory affairs experience and background, applying both strategic skills and execution.
- Business and personal computer hardware and software applications.
- Responding to requests for information and identifying key individuals who need to be involved to get things done.
- Ensuring that information provided is accurate and complete.
- Bachelor of Science Degree in biology or similar field, from an accredited college or university and a minimum of five (5) years of Regulatory Affairs In-Vitro Diagnostic Medical Device technical work experience, or an equivalent combination of education and experience.
- Advanced degree in Life Sciences field is preferred.
At Thermo Fisher Scientific, each one of our 50,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer. Apply today http://jobs.thermofisher.com
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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