Regulatory Affairs Associate

Summary

Join CellCarta, a leading Contract Research Organization, as a Regulatory Affairs Associate and contribute your expertise to ensure our in vitro diagnostic devices meet the highest standards. Reporting to the Vice President of Regulatory Affairs, you will prepare and approve regulatory submissions for new or modified IVD tests. Collaborate with various business units, maintain regulatory files, and support post-market surveillance. This role also involves developing regulatory and clinical processes, writing product labeling, and liaising with regulatory agencies. The position offers a dynamic environment, training opportunities, and a healthy work-life balance. Apply today to embark on an exciting career journey with CellCarta!

Requirements

• 0-3 years of experience in regulatory preferred but may consider quality assurance, clinical research/operations, research and development/support, software development, scientific affairs, operations, or related area
• Strong project management skills
• Demonstrates knowledge and understanding of global regulatory guidelines (i.e. US FDA, ISO13485, IVDR) with proven ability to successfully apply these to work output
• 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 train 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 and clinical processes
• Develops and maintains product labeling (e.g. technical information summaries, instructions for use etc.), advises team on labeling requirements
• Supports unique device identifier (UDI) and global unique device identifier database (GUDID) operations
• Serves as a liaison with regulatory agencies pertaining to product teams, as assigned
• Coordinates meetings with internal teams, and FDA as needed, including meeting agendas, minutes and action items
• Assist in the development of multi-country regulatory strategy and updates strategy based upon regulatory changes
• Assist in regulatory due diligence for potential and new acquisitions
• Utilize technical regulatory skills to propose strategies on complex issues
• Determine submission and approval requirements
• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams
• Participates in development teams to provide input on requirements and regulatory strategies for new diagnostic tests
• 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
• Manage and execute pre-approval compliance activities
• Review and approve advertising and promotional items to ensure regulatory compliance and ensure external communication meet regulations
• Demonstrates a commitment to the development, implementation and effectiveness of applicable regulatory processes as per IVDR, FDA, and other regulatory agency requirements
• Make decisions related to work processes or operational plans and schedules in order to achieve program objectives established by senior management

Preferred Qualifications

• Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred
• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society)

Benefits

• A dynamic and rapidly changing global environment allowing personal growth
• Training and personal development in a variety of (technical or people related) areas
• True career opportunities as the company grows fast
• A healthy work life balance with on-site and remote working
• A company that is fit for the future
• A competitive salary and benefits
• A great team you can work with