My client a world leading producer of unique and robust life science test solutions, providing “Immunoassays Beyond the Ordinary.” Are looking for a regulatory affairs manager. 

 Reporting straight to the VP of Quality & Regulatory, providing information, assistance and clarification to individuals concerning regulatory affairs, responsible for product submissions, periodic updates, and registrations to regulatory agencies. 

RESPONSIBILITIES

• Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies or to commercial partners, advise on the submission strategy for US and International submissions
• Review changes to existing products and SOPs to define the requirements for regulatory submissions
• Provide the regulatory reviews of customer complaints and define the regulatory reportability
• Maintain current knowledge of FDA and international regulation, guidance, and standards applicable to company products
• Represent Regulatory Affairs on R&D product development project teams to ensure all regulatory requirements are met throughout the development process

SKILLS AND QUALIFICATIONS

• Bachelor’s Degree (Master’s preferred) and 7-10 years in a GMP environment, In Vitro Diagnostic (IVD), Pharmaceutical, Life Science, Biotech or Medical Device experience preferred.
• Working knowledge of FDA regulations associated with operating a high-quality manufacturing environment.
• Solid track record at attaining FDA 510k clearances, DeNovo or PMA approvals preferably with reagent based IVD devices.

We aim to be an equal opportunity recruiter and we are determined to ensure that no applicant receives less favourable treatment on the grounds of gender, age, disability, religion, belief, sexual orientation, marital status, or race, or is disadvantaged by conditions or requirements.