
Director, Regulatory Affairs, LED
Welcome to Thermo Fisher Scientific, a global leader in scientific research and laboratory technology. We are currently seeking a highly qualified and motivated individual to join our team as the Director of Regulatory Affairs for our LED division. In this role, you will be responsible for ensuring compliance with all regulatory requirements related to LED products, as well as leading a team of regulatory professionals to support product development and market access. This is a dynamic and challenging position that offers the opportunity to make a significant impact on the success of our LED products. The ideal candidate will have a strong background in regulatory affairs and experience in the LED industry. If you are a driven and detail-oriented professional with a passion for regulatory compliance, we encourage you to apply for this exciting opportunity.
- Develop and implement strategies to ensure compliance with all regulatory requirements related to LED products.
- Lead and manage a team of regulatory professionals to support product development and market access.
- Collaborate with cross-functional teams to ensure timely and accurate submission of regulatory documentation.
- Keep abreast of changes in regulations and communicate updates and implications to relevant stakeholders.
- Act as a subject matter expert on regulatory requirements for LED products.
- Review and approve all regulatory submissions and ensure accuracy and completeness.
- Prepare and submit regulatory filings and maintain all necessary records and documentation.
- Develop and maintain relationships with regulatory agencies and represent the company in regulatory meetings.
- Conduct regulatory training for employees to ensure understanding and compliance with regulations.
- Monitor and track regulatory approvals and communicate status to relevant parties.
- Identify and mitigate potential regulatory risks and issues.
- Collaborate with quality assurance and product development teams to ensure compliance with regulatory requirements throughout the product lifecycle.
- Continuously improve and streamline regulatory processes to increase efficiency and effectiveness.
- Ensure all LED products meet applicable regulatory standards and requirements.
- Regularly report on the status of regulatory activities to senior management.
Bachelor's Or Master's Degree In A Scientific Field Such As Biology, Chemistry, Or Biomedical Engineering.
Minimum Of 7-10 Years Of Experience In Regulatory Affairs, Preferably In The Medical Device Or Diagnostics Industry.
Strong Knowledge Of Fda Regulations And Other Global Regulatory Requirements For Medical Devices And In Vitro Diagnostics.
Experience Leading A Team And Managing Projects In A Fast-Paced And Dynamic Environment.
Excellent Communication And Interpersonal Skills, With The Ability To Collaborate Effectively With Cross-Functional Teams And External Stakeholders.
Product Development
Quality Assurance
Technical Writing
Global regulations
Risk assessment
Regulatory compliance
Cross-Functional Collaboration
Product Registration
Regulatory Submissions
Regulatory Strategy
Labeling Requirements
Communication
Conflict Resolution
Emotional Intelligence
Leadership
Time management
creativity
Organizational skills
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Director, Regulatory Affairs, LED in Massachusetts, USA is between $157,000 and $183,000 per year. Factors such as level of experience, company size, and location can affect the specific salary for this role. Additionally, bonuses and benefits may also be included in the total compensation package.
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Thermo Fisher Scientific is a U.S.-based provisioner of scientific instrumentation, reagents and consumables, and software and services to healthcare, life science, and other laboratories in academia, government, and industry.

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