About the role:
We are seeking Regulatory Affairs Manager who will be reporting to the VP of Regulatory Affairs. This is hands-on working manager position will lead the day-to-day operational activities of the department and ensure that the project/s, department milestones and goals are met.
This position is based at Sciton's headquarters in Palo Alto, CAResponsible For
- Coordinate inspection of the organization and contract facilities (if applicable), provide support during audits and/or investigation(s) and develop procedures to ensure regulatory compliance.
- Oversee the regulation process for products requiring governmental approval and handling all domestic and international government interactions.
- Obtain regulatory approvals and certifications for the company as and when necessary; 510(k)'s, ISO 9001, ISO 13485, QSR, CE and foreign government regulatory approvals.
- Facilitate external inspections, audits and investigations; FDA (Fed and State), KFDA, ANVISA, etc., as well as TUV, EHS, fire department, etc., to ensure regulatory compliance.
- Perform internal audits annually and whenever necessary to ensure continued regulatory compliance.
- Generate CHRH product reports and maintain CDRH annual reports and VA quarterly reports.
- Process clinical complaints and maintain customer service and clinical complaints files for USFDA, EU-MDR, and regulatory reporting.
- Generate regulatory procedures as necessary to efficiently operate the business.
- Provide leadership to assure that products meet quantity, cost, quality and regulatory objectives.
- Support R & D efforts and direct product transfer to manufacturing.
- Improve manufacture of existing products by streamlining and automating processes where necessary.
- Generate and maintain all DHF's, including facilitating risk management, design reviews and formal product transfer.
- Has full authority for personnel actions.
Position RequirementsExperience / Education / Skill
- Direct experience with 510(k)'s, De Novo, IDE, CE, ANVISA, COFIPRIS, TGA, HC, MFDS, NMPA, PMDA, TFDA, etc. is highly desirable.
- Requires 10 years of experience in the related area as an individual contributor.
- 1 to 3 years supervisory experience is preferred.
- Requires a bachelor's degree in area of specialty, technical degree is preferred.
- Able to work with cross-functionally with other departments to understand the requirements that require support.
About the Organization SCITON is an industry leader and manufacturer of medical aesthetic lasers and light source technologies. With a vision to improve people's lives, our top-tier devices are built to order with integrity by pioneering, customer-focused, and results-driven individuals.
At the heart of it, innovation is a fundamental cornerstone of our culture. We strongly believe that new ideas can come from anyone, anywhere, at any time and embrace an open-door culture that welcomes and fosters individuals who are creative, driven, passionate, and willing to take the lead with us. Join us for an opportunity to grow and make an impact.Life At Sciton
At Sciton, people matter. We are more than a company; we are a family, which is why we give all our employees:
What Sciton Offers You
- The support, recognition, and room to grow their careers within Sciton.
- Empowerment to develop their creative genius and encouragement to be lifelong learners.
- Incentives for creativity and innovation across the organization.
- Competitive health benefits
- Income Protection
- Time off
- Professional Development
- Stock Options
- Discounted Programs
- Reward Programs
EOE Statement We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law.