Regulatory Affairs Project Manager

• 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.

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

• Remote position in US or Canada
• Flexible working hours to accommodate European colleagues
• Potential for travel to global CellCarta locations

• Competitive wages
• Medical, dental, and vision benefits
• 401k retirement savings plan with a healthy match
• Employee Assistance Program (EAP)
• Vacation and sick time
• Referral program
• Continuing education

The information collected to review your application will be processed by the human resources services of CellCarta Biosciences Inc. and its affiliates (collectively, “CellCarta”). The legal basis for this processing is the legitimate interest of CellCarta to evaluate the suitability of candidates for the roles available at CellCarta.

CellCarta will only process that information which is necessary to evaluate your application. This information includes identifying information such as your name, address, email address and phone number, as well as information about your education and professional experience, including previous positions and your CV. Such information is required for us to complete your applicant file, assess your suitability for the role and comply with applicable laws. CellCarta may obtain personal information from other sources, such as during reference, background, or employment checks, with your permission, and from third party sources such as recruitment and assessment sites or professional social media sites, in each case only if such information is relevant to reviewing your application. Your personal information will be retained only for so long as reasonably necessary and in accordance with applicable laws. This information will be processed confidentially and only accessed by those who have a need for the recruitment process. Please note that the information comprising your applicant file may be processed in a country that is not where you are located (for example, you might be in the European Economic Area or Québec, Canada, whereas your applicant file may be reviewed by CellCarta in the United States). If you are offered and accept employment with CellCarta Biosciences Inc. or one of its affiliates, the information collected will become part of your employment record. If you do not want us to retain your information, or want us to update it, please contact [email protected].