Overview:
The Regulatory Affairs Specialist II has primary responsibility for provision of In Vitro Diagnostic regulatory support to prepare, execute and maintain regulatory filings including change management, support of post market requirements and support of outside vendors [e.g. license holders, in country representatives].
Secondary responsibility would be to provide regulatory support to new product development teams to ensure product requirements/design inputs and design outputs enable identified planned regulatory filings.
The role will work through multiple levels and across functions within the Clinical Business Unit organization to support the growth of the IVD product portfolio.
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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