Regulatory Affairs Associate

Regulatory Affairs Associate

CellCarta

Antwerp or Remote, Belgium

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;
• 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;
• 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.

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;
• 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.

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