Job Title: Senior Regulatory Specialist
Region: USA - Hybrid
Come join our team!
Lutronic, a leading innovator of aesthetic and medical advanced laser and related technology, was established over 19 years ago to bring intuitive, robust, versatile devices which are affordable and efficacious to the worldwide medical community. Committed to improving medicine, Lutronic partners with key opinion leaders to advance science and ensure efficacy of its systems. All systems are versatile and offer multiple setting and treatment options for customized treatments, which optimize outcomes for a wide variety of conditions and treatments including melasma, tattoo removal, soft tissue incision, vascular, hair removal, wrinkles reduction, rejuvenation, body/face contouring, chronic pain, healing and more.
The Senior Regulatory Specialist position reports into our Vice President of Regulatory Affairs and is part of a matrixed environment which includes Clinical, Marketing, QA, and Manufacturing teams.
Hybrid: While this is a hybrid role, there is an expectation that the incumbent is available to commute to Billerica, MA 2-3 days per week.
In this role, you will be responsible for writing 510ks, reviewing proposed device changes for effect on current 510ks, regulatory review of promotional material, organizes regulatory information and tracks and controls submissions. and submission of FDA medwatch reports as well as providing responses back to the FDA. You will also work closely with our team in Korea on changes, as well as supporting the completion of international registrations such as CFG’s and other required documents as necessary.
- Must have prior experience with submitting 510 (k)s
- Experience with electromechanical and/or software devices
- Clear understanding of design controls
- Strong organizational, documentation
- Excellent attention to detail with strong organizational, documentation, and problem-solving capabilities
- Must also have strong interpersonal and relationship building skills
- Working knowledge of statistical data collection
- Ability to pivot to changes and shifting priorities effortlessly
- Computer knowledge (MS Office) and ability to learn various software programs and applications.
- Highly self-motivated employee with the ability to work in a growing and hyper-paced environment
Key Attributes to Help You Stand Out:
- BS or BA in engineering or scientific field preferred
- 3-5 years relevant experience within the regulatory discipline
- Experience in global settings
If you are looking for a fun, fast-paced growing company that values our team and offers products our customers love, we encourage you to apply today at www.lutronic.com.