Healgen Scientific is a global leader in developing, manufacturing and commercializing In-Vitro Diagnostic test systems. Since our inception in 2007, we have strived to develop devices that meet and exceed industry standards. Our comprehensive portfolio of high quality, tailored solutions span multiple testing categories and analytes to meet various clinical and laboratory needs. Our products include rapid visual tests, digital point of care (POC) devices, molecular diagnostics, and multiplex flow cytometry.

The purpose of a Regulatory Affairs Specialist is to ensure compliance with regulations and guidelines set by regulatory authorities in the medical devices industry. They play a crucial role in ensuring that products meet the necessary legal and quality standards before they can be marketed or sold.

Ensure timely and accurate regulatory submissions of medical device incident reporting.

Review and approve Healgen and private brand labeling.

Create and submit applications for medical device registration, private label requests, and licenses to regulatory bodies.

Ensure timely and accurate completion of all required documentation for product registration and licensing.

Collaborate with internal teams to gather necessary information and supporting documents for regulatory submissions.

Stay up-to-date with regulatory requirements and changes related to product registration and licensing.

Coordinate and track the progress of regulatory submissions and address any issues or deficiencies identified by regulatory authorities.

Maintain and update regulatory databases and records, including but not limited to product registrations and licenses.

Monitor and track the status of product registrations and licenses, ensuring compliance with renewal and maintenance requirements.

Provide guidance and support to internal stakeholders on product registration and licensing requirements and processes.

Collaborate with cross-functional teams to ensure alignment between regulatory requirements and product development plans.

Monitor and evaluate post-market data and feedback from customers, healthcare professionals, and regulatory authorities to identify potential product issues, safety concerns, or adverse events.

Collaborate with cross-functional teams to investigate and assess complaints, adverse events, and other post-market feedback.

Assist in developing and implementing regulatory strategies, gather regulatory requirements, support compliance activities, and contribute to strategy execution.

Complete other projects and responsibilities as assigned.

The Senior Level RA Specialist will perform the above duties with high independence and minimal guidance.

Education: Bachelor’s degree in a scientific discipline (biology, chemistry, bio-chemistry, genetics, or a heavily technical writing-based curriculum); MS or PhD preferred.

Experience: At least 3 years of work experience in the field. Experience with either 510(k) applications, PMA supplements and US device regulations or with EU and other international medical device regulations and submissions. Experience with medical device or IVD industry.

Skills and Competencies: In-depth knowledge of medical device regulations and standards, including FDA regulations (such as 21 CFR Part 820), ISO 13485, and other global regulatory requirements (such as MDR in the EU). Understanding of product development processes and ability to interpret technical documentation, including design specifications, verification and validation reports, and clinical data. Strong analytical and problem-solving skills to assess regulatory implications and find solutions to compliance challenges.

Strong written and verbal communication skills to effectively communicate with internal teams, external stakeholders, and regulatory authorities.

Attention to detail and ability to review and interpret complex regulatory documents, including regulatory submissions, labeling, and promotional materials.

Knowledge of quality management systems, including good manufacturing practices (GMP) and good documentation practices (GDP).

Certifications: Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)