Regulatory Affairs Specialist

·      Prepare, compile, submit, and maintain global regulatory submissions.

·      Support regulatory activities across the product lifecycle, including new product introductions, design changes, software releases, labeling updates, and change control processes.

·      Perform regulatory impact assessments for product changes and ensure timely updates to technical documentation and risk management files.

·      Maintain regulatory records, technical documentation, declarations, and evidence of conformity per applicable regulations and standards.

·      Review and approve labeling, IFUs, UDI and promotional materials to ensure compliance.

·      Provide regulatory guidance to R&D, Quality, Operations, Marketing, and Clinical teams;

·      Participate in audits/inspections and interface with regulatory bodies/certification bodies as needed.

·      3–5 years of hands-on regulatory affairs experience in the medical device industry- must.

·      Proven experience authoring and submitting Technical Files.

·      Demonstrated involvement in regulatory assessment of design changes, and labeling changes; strong change control and risk assessment practice- big advantage.

·      Solid experience with labeling compliance- big advantage.

Experience with SaMD/SiMDa and software lifecycle documentation (per IEC 62304), AI/ML-enabled devices, global labeling processes- big advantage.

·      Bachelor’s degree in Life Sciences, Biomedical Engineering, Regulatory Affairs, or related field (Master’s degree – advantage).

·      Strong working knowledge of EU MDR 2017/745, FDA 21 CFR 820, ISO 13485, ISO 14971, IEC 60601 series, and IEC 62304- big advantage.

·      Excellent written and verbal communication skills in English; strong documentation discipline and attention to detail.

·      Ability to manage multiple projects and collaborate effectively with cross-functional teams in a fast-paced environment.