Sr. Regulatory Manager

1 month ago

Watertown, United States Thermo Fisher Scientific Full time

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.

Location/Division Specific Information

At Thermo Fisher Scientific, the Regulatory Affairs function plays a vital role in ensuring compliance with the ever-evolving global regulations governing our industries. With a commitment to upholding the highest standards of quality, safety and compliance, our Regulatory team navigates complex landscapes to bring innovative products to market. They collaborate closely with cross-functional teams, such as Research and Development, Clinical Affairs, Quality Assurance, and Manufacturing, to develop and deliver regulatory strategies to obtain necessary approvals and maintain regulatory compliance throughout the product lifecycle. Our Regulatory professionals possess a deep understanding of international regulations and guidelines, staying abreast of emerging trends and industry best practices. They are champions of patient safety, working diligently to meet regulatory requirements while driving business growth. Join our dynamic Regulatory Affairs team and contribute to our mission to enable our customers to make the world healthier, cleaner and safer.

Discover Impactful Work:

As Sr. Regulatory Manager - Emerging Technologies & Cybersecurity , you will assume a key role in the interpretation and dissemination of global regulations, guidelines, and emerging industry developments that relate to AI, SAMD and cyber security. Applying your expertise, you will actively contribute to the continuous enhancement and alignment of our regulatory tools, including information systems, with our strategic objectives. You will provide guidance and support to the business relating to compliance with global regulations ensuring that our products meet all necessary requirements.

A day in the Life:

  • Interpret and communicate impact of relevant global regulations, guidelines and evolving regulatory trends.

  • Liaise externally with regulators, trade associations and other professional bodies to influence the development of related regulations.

  • Manage maintenance and improvements to regulatory tools, including regulatory information systems to meet organization objectives.

  • Act as Business Owner for RIMS tool providing oversight and management of upgrades and new implementations.

  • Partner with internal teams to drive Thermo Fisher strategy to address emerging regulations.

  • Guide and consult with the business on premarket submissions as well as post market surveillance and vigilance activities required for products containing AI and other digital technologies.

  • Create policies and guidelines to address emerging technologies and cybersecurity to ensure compliance.

Keys to Success:

Education

  • Bachelor’s degree in science, engineering or related field required.

Experience

  • Minimum of 8 years related experience or advanced degree with 6 years related experience.

Knowledge, Skills, Abilities

  • In-depth understanding of regulatory requirements and frameworks relevant to emerging technologies such as AI, digital health, and SAMD, and their impact on the product development process.

  • Ability to evaluate and analyze potential regulatory impact on new and existing products and provide strategic recommendations to minimize risks and ensure compliance.

  • Demonstrated ability to navigate regulatory authorities' requirements and effectively communicate with them to ensure timely and accurate submissions.

  • Exhibit excellent communication skills to effectively interact with internal customers, regulatory authorities, and cross-functional teams.

  • Clearly convey complex regulatory concepts, strategies, and requirements in a concise and persuasive manner. Strong presentation skills are also necessary to engage and influence key decision-makers.

  • Demonstrated advanced organizational and time management skills to efficiently prioritize and manage multiple complex projects simultaneously. Possess the ability to set realistic deadlines and adapt to changing priorities while maintaining high productivity and quality standards.

  • Demonstrated ability to lead without authority.

  • Proficient in using software and tools.

Physical Requirements / Work Environment

  • Regular interaction with cross-functional teams located globally.

  • Interaction with global Regulatory authorities.

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

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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