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 in the US and internationally. Collaborate with various business units, review submission documents, maintain regulatory files, and conduct post-market surveillance. You will also develop regulatory and clinical processes, maintain product labeling, and support UDI operations. This remote position offers flexible hours and potential travel. Apply today to embark on an exciting career journey!

Requirements

• Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred
• 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
• Assist in the development of multi-country regulatory strategy and updates strategy based upon regulatory changes
• 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

Preferred Qualifications

Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society)

Benefits

• Remote position in US (CST or EST preferred)
• Flexible working hours to accommodate European colleagues
• Potential for travel to global CellCarta locations
• Competitive wages: $54,200 - 72,300
• Medical, dental, and vision benefits
• 401k retirement savings plan with a healthy match
• Vacation and sick time
• Career development opportunities
• Continuing education