Regulatory Affairs Specialist II

Work ScheduleStandard (Mon-Fri)

Environmental ConditionsOffice

Job Description

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 the regulatory strategy defined by the business unit RA leadership. This position assists customers by providing regulatory support for the use of business unit products and services. Also, this position will ensure adherence to the company's established processes, policies, and procedures, as well as external regulatory requirements.

Responsibilities

• Responsible for execution of Class I, II (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, communicates renewal obligations to the cross-functional team ahead of time, and escalates if there is a lack of support from stakeholders
• Responsible for providing regulatory assistance in executing medium-level product optimization projects (Complexity Level L2, L3L), working 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 the New Product Development project
• Participates in product reviews and provides 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
• safely perform all job duties 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 devices 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 recommendations. Adaptability and flexibility to manage changing demands and handle substantial time pressures