Regulatory Affairs Specialist

Regulatory Affairs Specialist

Job Summary

The Regulatory Affairs Specialist plays a critical role in ensuring compliance with global regulatory requirements for in-vitro diagnostic (IVD) products. This position is responsible for preparing regulatory submissions, managing regulatory documentation, and collaborating with cross-functional teams to support new product development and market authorization activities. The Regulatory Affairs Specialist will also contribute to maintaining compliance with evolving regulations and standards, ensuring that the company meets its obligations across various global markets.

This role requires a detail-oriented professional with strong regulatory knowledge, excellent communication skills, and the ability to work collaboratively with internal teams and external regulatory agencies.

Key Responsibilities

Regulatory Submissions & Compliance

• Prepare and submit regulatory documentation, including 510(k) submissions, EU IVDR Technical Documentation, Health Canada filings, and other international market applications.
• Ensure regulatory submissions comply with applicable regulations and guidance from agencies such as the FDA, EU Notified Bodies, Health Canada, and other global authorities.
• Support regulatory strategies for new product development, product modifications, and ongoing compliance requirements.

Regulatory Support for Product Development & Market Authorization

• Assist in the development of regulatory strategies to support product approvals and clearances in target markets.
• Collaborate with R&D, Quality, Manufacturing, and Marketing teams to ensure regulatory requirements are considered during product development.
• Participate in regulatory impact assessments for design changes, labeling updates, and manufacturing modifications.

Regulatory Intelligence & Documentation

• Monitor and interpret changes in global regulations, guidance documents, and industry standards to ensure compliance.
• Maintain regulatory files, technical documentation, and internal records in accordance with regulatory requirements and company policies.
• Provide regulatory input for advertising, promotional materials, and scientific publications to ensure compliance with applicable advertising and labeling regulations.

Collaboration & Communication

• Act as a liaison between the company and regulatory authorities to facilitate communication, respond to inquiries, and provide necessary documentation.
• Work closely with global regulatory partners to support international product registrations and compliance initiatives.
• Educate internal teams on regulatory changes and best practices to ensure ongoing compliance and awareness.

Qualifications & Experience

Education:

• Bachelor’s degree in Biomedical Engineering, Biochemistry, Molecular Biology, Chemistry, or a related scientific discipline required.
• Regulatory Affairs Certification (RAC) is a plus.

Experience:

• 3–5 years of regulatory affairs experience in the medical device or in-vitro diagnostics (IVD) industry.
• Hands-on experience preparing regulatory submissions such as 510(k), IVDR Technical Documentation, and international regulatory filings.
• Familiarity with IVD product development processes, including analytical and clinical validation requirements.
• Experience working with FDA, EU IVDR, Health Canada, and other global regulatory bodies.

Skills & Capabilities:

• Strong knowledge of regulatory requirements for medical devices and IVDs in major markets (U.S., EU, Canada, Australia, etc.).
• Ability to interpret and apply regulatory guidance documents, standards, and policies.
• Strong organizational skills with the ability to manage multiple projects and deadlines in a dynamic environment.
• Excellent written and verbal communication skills, with experience in scientific writing and regulatory documentation.
• Proficiency in Microsoft Office Suite and electronic document management systems.

Additional Information

• Travel: Limited (<10%), as required for regulatory meetings and training.
• Work Environment: This role involves collaborating with cross-functional teams in a fast-paced regulatory setting.

This position offers a unique opportunity to contribute to a dynamic Regulatory Affairs team, ensuring compliance with evolving global regulations while supporting innovative healthcare solutions. If you are passionate about regulatory compliance and product approvals, we encourage you to apply.