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Regulatory Affairs Analyst II

Regulatory Affairs Analyst II

Waters CorporationBengaluru, Karnataka, India
12 hours ago
Job description

Responsibilities

Responsibilities :

Maintaining / Sustaining regulatory filings

  • Act as regulatory affairs lead for filing regulatory submissions for existing products for new geographies.
  • Develop and maintain regulatory strategies for new and modified product / product families
  • Conduct international registrations in accordance with and in support of regulatory strategies
  • Provide input on and approve product labels and labelling including language requirements worldwide
  • Support set up and management of outside vendors such as License holders and In Country agents (including importers, distributors), as needed.

New Product Development

  • Act as Regulatory Affairs lead for the new product development projects, provide "solution-based" advice to development teams
  • Develop and maintain regulatory strategies for new and modified product / product families
  • Prepare and execute regulatory filings such as technical files, Canadian submissions, and letters to file.
  • Conduct international registrations in accordance with and in support of regulatory strategies
  • Provide input on and approve product labels and labelling including language requirements worldwide
  • Support set up and management of outside vendors such as License holders and In Country agents (including importers, distributors), as needed.
  • Change Management

  • Provide regulatory guidance on changes to existing products
  • Monitor global regulatory intelligence, provide impact evaluation to changing regulations.
  • Performing regulatory impact assessments for engineering changes
  • Review and approve promotional materials
  • Post Market

  • Provide regulatory input to support post market surveillance and vigilance activities
  • Support Health Hazard Assessments and Field Actions as needed
  • Qualifications

    Education :

  • Bachelor’s degree required, preferably in Analytical Chemistry, Biochemistry, or Biomedical Engineering. Graduate education is preferable.
  • Experience :

  • Regulatory affairs experience in the In Vitro Diagnostic Medical Device environment, or equivalent
  • Knowledge and application of 21 CFR 820 and ISO 13485 is required
  • Knowledge and application of the India and APAC specific IVD regulations is required
  • First-hand experience with preparation and execution of regulatory filings such as premarket notifications, licence applications & technical files, preferably for clinical IVD products
  • Skills :

  • High fluency in English, verbal and written
  • Critical Thinking, Active Listening, and Technical Writing Skills
  • Able to work effectively in a global function
  • Strong ability to work with individuals / teams dispersed across many different locations, timezones and cultures (US, EU, China, India, Australasia)
  • Strong organization / prioritization skills
  • Outstanding Work Ethic.
  • Effective communication and influencing skills.
  • Team player demonstrating good organizational and communication skills
  • Self-starting demonstrating initiative
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    Analyst • Bengaluru, Karnataka, India