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Thermo Fisher Scientific

Waltham, MA

Sr Manager, Regulatory Affairs - Remote - Work From Home

Employment TypeContractor
Date Posted2022-08-07
Direct Apply
Valid Through2023-06-26

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.

What will you do?

As Senior Manager, Regulatory Affairs you will be responsible for developing a multi-faceted and high-functioning Regulatory Affairs team at the Thermo Fisher Scientific, Clinical Diagnostics Divisional level. The Clinical Diagnostics Division (CDD) is an organization made up of business units which develop, manufacture and market instruments and consumables that serve a broad, diverse mix of diagnostic segments. The major business units include Niche Diagnostics, Biomarkers, Clinical Mass Spectrometry, Analyzers and Automation and Clinical Diagnostic Reagents.

This Senior Manager will be experienced with successful IVD product submissions, globally. Expertise in writing US FDA and Health Canada submissions is strongly desired. You will be responsible in developing Regulatory Team members in these submissions.

How will you make an impact?

This is a highly visible role at the site and Division level, you will report to the Senior Director of Regulatory Affairs. The Senior Manager will participate in regulatory strategy development and its implementation across the Clinical Diagnostics businesses, including formulation of strategies for new products and markets. We will work together to implement a best-in-class regulatory team that meets the needs of our diverse mix of diagnostic segments!

Key Responsibilities:

Develop regulatory staff to build a best-in-class global regulatory team. Lead, motivate and guide associates in a matrix organization on industry-leading practices. Attracts and develops top talent to build an outstanding regulatory function.

Advise the business unit regulatory teams on the optimal regulatory strategies, submissions, and approval pathways.

Partner with R&D, marketing, operations and legal leadership within the division and hold the businesses accountable for delivering on agreed timelines and global commercialization approaches.

Provide regulatory strategy leadership and expertise to enable an optimized go-to-market approach for both CDD business functions and IVD OEM partners.

Lead interactions with FDA & global regulatory authorities to gain alignment on regulatory strategies and resolve concerns to expedite approval of pending applications. Remain well-versed in evolving global regulatory policies and advise business units internally on anticipated changes, net business effect and develop appropriate strategies/processes to appropriately address.

Oversee regulatory communications with marketing to ensure appropriate approval of commercial literature and language.

How will you get here?

  • A minimum of 7+ years of regulatory affairs experience that includes FDA as well as global health authority interactions.

  • Particular expertise in the US and Canadian markets is desired.

  • Undergraduate degree in scientific field required; advanced degree preferred.

  • Hands-on experience with classification of devices; listing, registration, and approval of devices required; adverse event reporting, and recalls desired.

  • Experience interpreting and working under the regulations governing the approval of new products and the expectations and processes employed by the FDA and EU agencies, CE mark, 510k, PMA, EUA, technical files and design dossier. Additional experience with similar ex-US regulators (e.g. Japan PMDA, China NMPA, Brazil ANVISA, Health Canada etc.) ideal.

  • Possess IVD technical expertise and regulatory knowledge to lead products through the approval and commercialization phases.

  • Experienced in direct, professional, regulatory interactions with customers and OEM business partners.

  • Technically savvy using IT databases and familiarity with commercial digital tools desired.

  • Ability to get results in a matrixed organization, especially having representatives from different cultures come together, embracing diversity.

  • Travel Requirements: 20% regional and international travel

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 global 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.

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.

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at ******. Please include your contact information and specific details about your required accommodation to support you during the job application process.

*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.

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.

Job ID: 3619438285320812037

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