· 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.
You already know we create amazing technology that helps millions around the world to live better, more confident lives. You also know that we are at the top of the medical aesthetic market.
But we’re here to tell you we are way more than that.
We realized that in the modern life, a better way to make innovative technology, is understanding what our partners and their patients really want. To put people and their needs first. So we became better at listening and translating the true needs of your patients into outstanding and cutting-edge technology.
We are transforming together. With you. This is what we been doing for the last 20 years. This is what got us to be a leading player in the medical aesthetics field. We take pride being number 1 in China and number 3 globally, and we owe this accomplishment to our people, our partners and our daring spirit. We infuse this spirit in everything we do and we invite you to join us.
Whatever comes next we are there.
Alma Lasers is a global innovator of laser, light-based, radiofrequency and ultrasound solutions for the aesthetic and surgical markets.
Alma Lasers has been at the forefront of multi-technology systems, revolutionizing existing treatment methods and working to serve the varied and growing needs of both patients and practitioners around the world.
With offices, R&D and manufacturing facilities on three continents and distributors around the world, Alma's mission is to provide modular, cost-effective and high-performance systems based on the very latest clinical research and cutting-edge technology. We enable practitioners to offer safe, effective and profitable aesthetic and surgical treatments to their patients, while allowing patients to benefit from the capabilities of state-of-the-art, clinically proven technologies and methods.
