Senior Regulatory Affairs Specialist

5-7 years
a month ago 4 Applied
Job Description

Job Title

Senior Regulatory Affairs Specialist

Job Description

Job title: Senior Regulatory affairs specialist

Reports to: Regulatory Affairs Lead

Location: Bangalore

Position Summary:

The Regulatory Affairs Specialist supports and implements product regulatory plans, provides guidance on global regulatory strategy and product registrations, participates in and advise cross-functional new product/solution development teams on applicable regulations, requirements and standards.

Responsibilities:

  • Responsible for regulatory planning for new product introductions and product changes, and assist in maintaining, regulatory compliance.
  • Product submissions, global registrations and communication with authorities
  • Managing compliance to global regulations, standards and guidelines Guide R&D, clinical and marketing teams regarding regulatory related considerations
  • Regulatory support for internal audits, external audits and inspections.
  • Recommends changes for labelling to ensure regulatory compliance.
  • Monitors and improves tracking/control systems.
  • Keeps abreast of regulatory procedures and changes.
  • Represent Regulatory Affairs as team member of product development projects.
  • Monitor and provide information pertaining to impact of changes in the regulatory environment
  • Author and/or review regulatory procedures and update as necessary.
  • Review SW release documents and ascertain regulatory impact for external and internal documents through formal regulatory assessments.

Education/Skills and Experience Requirements:

Minimum:

  • Academic degree in computer science, biological sciences, engineering or equivalent
  • At Least 5 years experience in regulatory roles, in Medical Devices companies.
  • Fluent English
  • Good analytical skills and writing skills
  • Good understanding of the Quality System Regulation (ISO 13485, MDR, 21 CFR Parts 803, 806 and 820)
  • Experience with regulatory submissions in multiple jurisdictions.
  • Experience with business-related implementation projects, including being an active leadercontributor on projects with scheduled deliverables.
  • Ability to interact and communicate in English, including demonstrable writing, speaking, and comprehension skills ability to communicate across levels of the organization

Preferred:

  • Software Medical Devices companies - an advantage
  • Good understanding of application of IEC 62304, IEC 62366, ISO14971
  • Additional knowledge on cybersecurity, privacy and/or cloud services.

JOB TYPE

Industry

Function

Skills

ISO14971
806
IEC 62366
MDR
820
21 CFR Parts 803

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