Job Summary: We are seeking a highly skilled and experienced Regulatory Affairs Specialist to join the ACCU Reference team. The ideal candidate will have extensive experience in FDA interactions, submissions, and approvals, with a particular focus on 510(k) submissions. Additionally, the candidate should possess a strong background in the regulatory aspects of In Vitro Diagnostics (IVD). This role will be critical in ensuring that our tests meet all regulatory requirements and achieve all the phases’ s timelines for the LDT to IVD transition dictated by the “Final FDA rule regulating laboratory-developed tests”.

Key Responsibilities:

FDA Interactions and Submissions:

- Prepare and submit medical device reporting system (adverse event reporting, correction, and removal standards) and LDT/IVD registration and labeling to the FDA.

- Prepare and submit 510(k) premarket notifications to the FDA.

- Lead communications with FDA representatives to address inquiries and provide additional information as needed.

 - Develop and maintain a comprehensive understanding of FDA regulations and guidance documents.

 - Monitor changes in FDA regulations and ensure compliance for existing and new products. 

Regulatory Strategy and Compliance:

- Develop regulatory strategies for product submissions, including premarket notifications, technical files, and labeling.

- Ensure all regulatory documentation is complete, accurate, and in compliance with applicable standards.

- Liaise with internal teams to enforce quality controls and LDTs align with FDA regulatory requirements.

 IVD Regulatory Aspects:

 - Prepare regulatory submissions and approvals for LDTs as In Vitro Diagnostic devices.

 - Ensure compliance with ISO 13485, IVDR, and other relevant standards and regulations.

- Review and approve labeling, advertising, and promotional materials for IVD products.

Documentation and Reporting:

- Prepare and maintain regulatory submissions, technical files, and regulatory reports.

 - Manage regulatory documentation to ensure it is current and readily available for internal and external audits and FDA inspections.

- Develop and implement standard operating procedures (SOPs) for regulatory processes.

Regulatory Intelligence:

- Stay current with regulatory developments and industry trends related to FDA and IVD regulations.

 - Provide regulatory intelligence and risk assessments to the management team.

 - Participate in industry forums, workshops, and training sessions to enhance regulatory knowledge and skills.

Minimum Qualifications:

- Bachelor’s degree in a scientific or engineering discipline (e.g., Biology, Chemistry, Biomedical Engineering).

 - Minimum of 5 years of experience in regulatory affairs, with a focus on FDA submissions and IVD products.

- Demonstrated experience with 510(k) submissions and FDA interaction.

- Strong knowledge of FDA regulations, ISO 13485, IVDR, and other relevant regulatory standards.

 - Excellent communication and negotiation skills, with the ability to effectively interact with regulatory agencies.

- Detail-oriented with strong organizational and project management skills.

- Ability to work independently and collaboratively in a fast-paced environment.

Preferred Qualifications:

 - Advanced degree in Regulatory Affairs or related field.

- RAC (Regulatory Affairs Certification) or similar certification.

Work Environment:

- May include some travel

 - On-site in Linden, New Jersey

Note: This job description is intended to convey information essential to understanding the scope of the Regulatory Affairs Specialist position. It is not intended to be an exhaustive list of qualifications, skills, duties, or responsibilities associated with the role.