Regulatory Affairs Specialist II

  Regulatory Affairs

Job title: Regulatory Affairs Specialist II

Company: Thermo Fisher Scientific

Job description: Job Description

Job Title : Regulatory Affairs Specialist II

Job Location : Hyderabad

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. Visit us at

India Engineering Centre is a Global R&D centre which provides Product development services to the Global Business units. Our Product development ranges from Laboratory equipments, Analytical instruments, remote monitoring solutions, Chromatography & Mass spectrometry.

Role Description :

Divisional role as one of the Regulatory Affairs core team members supporting both manufactured and OEM products for the Business Unit (BU). The IEC arm of Regulatory Affairs (RA) is responsible for facilitating and executing regulatory strategy defined by the business unit RA leadership. This position assists customers by providing regulatory support as it applies to the use of business unit products and services. Also, this position will ensure adherence to established processes, policies, and procedures of the company and external regulatory agencies.

Responsibilities :

  • Responsible for execution of Class I (or equivalent) medical device product registrations in various countries/geographies interfacing with the cross-functional teams (Engineering, Operations, Quality, Sales & Registration Agents )
  • Reviews and organizes dossiers and submission packages for agencies communicate renewal obligations to the cross-functional team ahead of time and escalate if there is a lack of support from stakeholders
  • Responsible for providing regulatory assistance in executing Medium level product optimization projects (Complexity Level L2), work with product certification agencies like UL to update the reports if the proposed product change is critical to the safety performance. Monitor and manage RA project timelines and provide updates to project stakeholders.
  • Assist in interactions with outside experts, partners, and regulatory agencies to understand market access requirements for specific products
  • Organize technical meetings with regulatory agencies to understand failures/challenges, if any, and facilitate closure working with the CFT team
  • Organize materials from preclinical and clinical studies for review and assist in the review process
  • Assist in peer review of regulatory tasks associated with New Product Development project
  • Participates in product reviews and provide a compliance review of each stage gate for both internal product designs or simple OEM branding projects
  • Stay abreast of regulatory procedures and changes in the regulatory climate
  • Participation and adherence to internal audit requirements per QMS, assist in quality control of regulatory documents and submissions
  • Perform all job duties in a safe manner and obey all safety policies and procedures
  • Act in compliance with the Thermo Fisher Code of Ethics and the 4-I Values (Integrity, Intensity, Involvement, and Innovation)

Qualification & Experience * Graduate degree in Science or Engineering

  • 5 + years of experience in regulatory affairs of Laboratory products / medical device or any other regulated industry
  • Basic knowledge / experience in understanding and dealing with relevant directives and standards (such as the Machinery Directive, Low Voltage Directive, EN / ISO 61010, EMC, CE, etc.)
  • Basic knowledge in the field of product approval and product safety requirements
  • Shall have a minimum of 3 years of experience in global regulatory requirements of product, processes, and procedures.
  • Experience in Safety, EMC & Wireless testing of products would be an added advantage

Skills & Knowledge * Ability to work independently with minimal supervision

  • Willingness to learn new things and apply the same with strong attention to detail
  • Quick learner who is adaptable and willing to work with the team (strong team player)
  • Ability to communicate requirements and collaborate with internal and external stakeholders in completing the assigned tasks/projects
  • Flexibility to manage changing demands and handle substantial time pressures
  • Understanding and interpretation of regulatory requirements, legislation, processes, and procedures
  • Ability to analyze data and information and clearly articulate the findings and provide recommendationsAdaptability and flexibility to manage changing demands and handle substantial time pressures
  • At Thermo Fisher Scientific, each one of our 130,000 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

Job Category

Research & Development

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.

Expected salary:

Location: Hyderabad, Telangana

Job date: Wed, 29 Jun 2022 01:30:32 GMT

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