About the Role

We are seeking a motivated Regulatory Specialist with 3-5 years of experience to join our dynamic team. This role will support key regulatory activities for our diagnostics products, ensuring compliance with global regulations and standards. The ideal candidate is detail-oriented, collaborative, and capable of driving results in a fast-paced environment.

Responsibilities

• Prepare, review, and submit regulatory documentation, including pre-market submissions (e.g., 510(k), EU technical files, or IVDR-related documents).
• Ensure compliance with applicable regulatory requirements (FDA, CLIA, MDR/IVDR, ISO 13485, etc.) for diagnostic products.
• Assist in the development, implementation, and maintenance of regulatory strategies for new and existing products.
• Liaise with cross-functional teams (e.g., R&D, Quality, Clinical) to gather required technical information for regulatory submissions.
• Monitor regulatory changes and trends, assessing their impact on the company’s products and processes.
• Support external audits and inspections, providing required documentation and ensuring timely follow-up on regulatory actions.
• Maintain regulatory databases, track submission timelines, and ensure accurate record-keeping.
• Provide regulatory input for labeling, promotional materials, and product development initiatives.

Qualifications

• Bachelor’s degree in life sciences, engineering, or a related field.
• 3-5 years of experience in regulatory affairs, preferably in the diagnostic or medical device industry.
• Familiarity with regulatory requirements and standards, including FDA (21 CFR Part 820), EU MDR/IVDR, ISO 13485, and CLIA/CAP compliance.
• Experience with regulatory submissions, such as 510(k) or EU technical documentation.
• Excellent written and verbal communication skills, with a strong attention to detail.
• Proven ability to manage multiple projects and meet deadlines in a fast-paced environment.
• Proficiency in regulatory software tools and document management systems is a plus.

Preferred Skills

• Experience working with in vitro diagnostics (IVD) products.
• Knowledge of hybrid quality systems for LDTs and medical device requirements.
• Familiarity with global regulatory frameworks, including Health Canada, PMDA, or TGA.