What are the responsibilities and job description for the Regulatory Affairs Project Manager position at CellCarta?
Eager to embark on a new professional journey that will transform your career? CellCarta, a leading Contract Research Organization, is hiring a Regulatory Affairs Project Manager to join our dynamic team. As a Regulatory Affairs Project Manager, 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
The Regulatory Affairs Project Manager 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. The position will work closely with functional business units, perform regulatory review of submission documents, maintain regulatory files, and facilitate regulatory post market surveillance.
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.
- 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
We offer a wide range of benefits including:
- Competitive wages: $83,000 - 110,000
- 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
CellCarta is a leading provider of specialized precision medicine laboratory services to the biopharmaceutical industry. Leveraging its integrated analytical platforms in immunology, histopathology, proteomics, and genomics, as well as related specimen collection and logistics services, CellCarta supports the entire drug development cycle, from discovery to late-stage clinical trials. The Company operates globally with facilities located in Canada, USA, Belgium, Australia, and China.
Joining CellCarta means working with 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!
Join us as we make an impact on 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 privacy@cellcarta.com.
Salary : $83,000 - $110,000
