Job description
Regulatory Affairs Associate
Eager to embark on a new professional journey that will transform your career? CellCarta, a leading Contract Research Organization, is hiring a Regulatory Affairs Associate to join our dynamic team. As a Regulatory Affairs Associate, you will have the opportunity to use your expertise and skills to ensure that our in vitro diagnostic devices meet the highest industry standards. Come work with a team of talented individuals who are committed to making a positive impact on human health and well-being. Apply today and take the first step towards an exciting new career with CellCarta!
Summary
Reporting to the Vice President of Regulatory Affairs, the Regulatory Affairs Associate is responsible for the preparation and approval of regulatory submissions required to market new or modified in vitro diagnostic devices (IVD) tests in the US and in international markets, as assigned. The position will work closely with functional business units, perform regulatory review of submission documents, maintain regulatory files, and facilitate regulatory post market surveillance. The role is also responsible for writing regulatory and clinical processes to support diagnostic development programs.
Main 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.
Education
- 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).
Main 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.
Working Conditions
- Remote position in US (CST or EST preferred)
- Flexible working hours to accommodate European colleagues
- Potential for travel to global CellCarta locations
Benefits
CellCarta is made up of dedicated professionals who are focused on achieving our mission of impacting the future of patient therapy. We make a difference in the lives of patients around the world!
We offer a wide range of benefits including:
- 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
About Us
CellCarta is a rapidly growing, stable company. We are a leading provider of pre-clinical and clinical trial services to pharmaceutical and biotechnology companies. Our laboratory service offerings include immunohistochemistry, FISH, CTC isolation and characterization, chemosensitivity testing, tissue procurement, flow cytometry, ELISA, mutation testing, cell expansion, and colony-forming assays. CellCarta is a CLIA-licensed and CAP-accredited laboratory, and we perform studies in compliance with the relevant portions of Good Laboratory and Good Clinical Practices.
Join us as we make an impact on the future of patient therapy!
Supplemental Information
Candidates must be legally authorized to work in the United States on a permanent basis. Verification of employment eligibility will be required at the time of hire. Visa sponsorship is not available.
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].
