Welcome to Thermo Fisher Scientific, a global leader in scientific research and development. We are seeking a highly motivated and experienced Sr Regulatory Affairs Specialist to join our team. As a Sr Regulatory Affairs Specialist, you will play a crucial role in ensuring compliance with regulatory requirements for our products. This is an exciting opportunity for an individual with a strong background in regulatory affairs and a passion for ensuring the safety and efficacy of our products. If you have a keen attention to detail, excellent communication skills, and a desire to make a meaningful impact in the scientific community, we invite you to apply for this role.
- Develop and maintain a thorough understanding of regulatory requirements for all relevant markets and products.
- Interpret and communicate regulatory requirements to cross-functional teams to ensure compliance in all aspects of product development.
- Prepare and submit regulatory submissions, including premarket notifications, registrations, and renewals to regulatory authorities.
- Review and approve product labeling, advertising, and promotional materials to ensure compliance with regulatory requirements.
- Conduct thorough research and analysis of regulatory issues and provide recommendations to mitigate risks and ensure compliance.
- Monitor and communicate changes in regulations and advise the company on potential impact to current and future products.
- Collaborate with internal and external stakeholders, such as cross-functional teams, regulatory agencies, and third-party consultants, to ensure timely and successful product approvals.
- Maintain all regulatory documentation and records in accordance with company policies and regulatory standards.
- Participate in internal and external audits and inspections, providing necessary documentation and support as needed.
- Serve as a subject matter expert on regulatory affairs and provide guidance and training to other team members as needed.
- Continuously monitor and improve regulatory processes and procedures to ensure efficiency and compliance.
- Stay current with industry trends and best practices in regulatory affairs to identify opportunities for process improvement and innovation.
- Represent the company in external meetings and conferences related to regulatory affairs.
- Uphold Thermo Fisher Scientific's values and standards in all interactions and practices.
A Minimum Of 5 Years Of Experience In The Field Of Regulatory Affairs, Preferably In The Life Sciences Or Medical Device Industry.
In-Depth Knowledge Of Fda Regulations And Guidelines, As Well As International Regulatory Requirements.
Strong Understanding Of Product Registration Processes And Submission Requirements.
Experience In Developing And Implementing Regulatory Strategies For New Product Launches And Product Changes.
Excellent Communication And Interpersonal Skills, With The Ability To Effectively Collaborate With Cross-Functional Teams And Communicate With Regulatory Authorities.
Quality Assurance
Project Management
Technical Writing
Global regulations
Change control
Risk assessment
Regulatory compliance
Product
Audit Preparation
Product Registration
Regulatory Submissions
Labeling Requirements
Communication
Conflict Resolution
Emotional Intelligence
Leadership
Time management
creativity
Teamwork
Active Listening
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Sr Reg Affairs Spec is $70,000 - $110,000 per year. However, this can vary depending on a variety of factors such as location, years of experience, and specific job responsibilities.
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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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