Regulatory Affairs Project Manager

Summary

Join CellCarta, a leading Contract Research Organization, as a Regulatory Affairs Project Manager. You will be responsible for preparing and approving regulatory submissions for in vitro diagnostic devices. This role involves close collaboration with various business units, regulatory document review, file maintenance, and post-market surveillance. You will develop and maintain regulatory processes, procedures, and product labeling. The position requires strong project management skills and a deep understanding of global regulatory guidelines. CellCarta offers a remote position with flexible hours and a comprehensive benefits package.

Requirements

• Bachelor's degree (or equivalent) in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred
• 2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, software development. scientific affairs, operations, or related area
• 4-5 years experience in a regulated industry
• Demonstrates knowledge and understanding of global regulatory guidelines (i.e. US FDA, ISO13485, IVDR) with proven ability to successfully apply these to work output
• Strong project management skills
• Exercises judgment within well-defined and established procedures and practices to determine appropriate action
• Ability to work independently and in a team environment
• Detail-oriented with good organization and time management skills
• Strong interpersonal and verbal/written communication skills
• Able to respond quickly to shifting priorities and to meeting deadlines

Responsibilities

• Develops regulatory processes and procedures aligned with global regulatory requirements and trains key personnel in accordance with these processes and procedures
• Assembles, prepares and/or reviews and submits pre-market authorization/pre-submission packages, supplements, amendments, technical files and other documents to regulatory agencies in line with regulatory requirements and guidelines
• Interacts effectively with functional business units to coordinate/facilitate development of documentation required for submissions, ensuring that project timelines are met
• Maintains general working knowledge of current and evolving state, federal (e.g., 21 CFR 820) and international procedures (e.g., IVDR and other worldwide regulatory regulations as appropriate and standards, e.g., ISO 13485, ISO 14971) relevant to the registration/clearance/approval and post-market surveillance of IVDs
• Develops and supports implementation and maintenance of regulatory processes
• Develops and maintains product labeling (e.g. technical information summaries, instructions for use etc.), advises team on labeling requirements
• Assist in the development of multi-country regulatory strategy and updates strategy based upon regulatory changes
• Participates in development teams to provide input on requirements and regulatory strategies for new diagnostic tests
• Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval
• Monitor changing FDA and EU regulations and guidance to assess regulatory impact on submission strategies and update internal stakeholders
• Monitor applications under regulatory review and communicate application progress to internal stakeholders

Preferred Qualifications

Prior work with IVDs, molecular diagnostics, IHC, PCR-based assays, sequencing technologies and/or CLIA laboratories is highly desirable

Benefits

• Competitive Wages
• Vacation and Personal Days
• Comprehensive Group Insurance Plans
• RRSP Contribution with Employer Matching
• Employee Annual Incentive Plan (EAIP)
• Dialogue Telemedicine Service and Employee Assistance Program (EAP)
• OPUS & Cie Contribution
• Referral Program
• Career Advancement Opportunities
• Remote position in US or Canada
• Flexible working hours to accommodate European colleagues
• Potential for travel to global CellCarta locations