Regulatory Affairs Specialist

Description:

About Dynex: Founded 70 years ago, DYNEX® TECHNOLOGIES, Inc., is a leading designer and manufacturer of fully automated ELISA microplate workstations, laboratory instruments and associated consumables and accessories, seamlessly integrating advanced detection with fully automated sample handling. Our talented, multidisciplinary staff includes design and service engineers, applications scientists, marketing specialists and precision-manufacturing experts. All dedicated to perpetual innovation in product design and new application frontiers to deliver cutting-edge microplate processing systems that meet the rigorous demands of the most challenging applications and ultimately improve health outcomes and enhance life.

Job Summary: The Regulatory Affairs Specialist supports global regulatory submissions, registrations, labeling, and compliance activities related to Class I ELISA instruments, consumables, and service parts. This role is ideal for a regulatory professional who is comfortable operating in a fast-paced environment with evolving requirements and multiple jurisdictions.

Requirements:

Essential Functions:

• Assist in maintaining device registrations, listings, and international dossiers (FDA FURLS, IVDR documentation, etc.).
• Support updates to global product technical files, labeling, and IFU compliance (including translations management).
• Assist with regulatory impact assessments for engineering changes, ECNs/ECOs, software releases, and packaging revisions.
• Participate in regulatory renewals, annual listings and reporting, regulatory intelligence monitoring, and regulatory surveillance.
• Support preparation and/or compilation of regulatory submissions to competent authorities, distributors, or authorized representatives.
• Assist cross-functional partners (QA, Innovation, Operations, Service, Commercial) to ensure compliance with relevant regulations.
• Support Complaints/Vigilance/Post Market Surveillance documentation as needed (FDA 806/803 support, IMDRF codes, etc. if applicable).
• Maintain regulatory records in accordance with QMS procedures and document control requirements.
• Support inspection readiness and audit activities (FDA, NB, MDSAP — when applicable).
• Additional duties as assigned.

Supervisory Responsibilities: None.

Success Factors: To be able to work independently and to lead project teams. To stay up to date with the current regulatory changes. To be able to communicate effectively through both written media and verbally. Strong mediation and negotiation skills.

Minimum Qualifications/Education:

Required:

• Bachelor’s degree in a scientific, engineering, regulatory, or related field. Equivalent, extensive relevant experience may be considered in lieu of a degree.
• ~2–3 years of regulatory affairs experience in a regulated industry (medical device preferred; biotech, pharma, combination products, or other FDA-regulated sector acceptable).
• Working knowledge of FDA medical device framework (21 CFR 820/QMSR, 21 CFR 807), EU IVDR and ISO 13485.
• Ability to understand, interpret, and apply regulatory requirements.
• Excellent communication, technical writing, and documentation skills.

Preferred:

• Experience with Class I medical devices, IVDs, and/or laboratory instrumentation.
• Experience with international markets (EU IVDR, Health Canada, LATAM, APAC, MEA etc.).
• Familiarity with IFU translation and medical device labeling requirements.
• Regulatory Affairs Certification (RAC) or progress toward RAC.

Computer Skills: Computer literacy in Windows, Word, Excel, Power point and Visio.

Work Environment: On-site Office.

Physical Requirements: Must be able to meet National Institute for Occupational Safety & Health (NIOSH) Standards.

NPM16