Global Regulatory Affairs Specialist II

Responsibilities

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 European IVD regulations is required, IVDR preferred First-hand experience with preparation and execution of regulatory filings such as pre-Submissions, premarket notifications, & technical files for US & EU regulatory approval, 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 and cultures Strong organization/prioritization skills Outstanding Work Ethic. Effective communication and influencing skills. Team player demonstrating good organizational and communication skills Self-starting demonstrating initiative