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