Regulatory Affairs Specialist

Description:

Alma, a Sisram Medical company, is a global leader in medical-aesthetic technologies, with over 25 years of experience in energy-based devices (EBD). Over the years, Alma has evolved into an integrated aesthetic and wellness ecosystem that combines medical devices, injectables, diagnostics, and personalized skincare. The company operates in a dynamic, innovation-driven environment, merging advanced technology with deep clinical understanding to create holistic solutions for aesthetic clinics. Alma’s headquarters are in Caesarea, Israel, with business operations in more than 100 countries worldwide.

·      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.

·      At least 2 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.