Director of Quality & Regulatory
Forward Science, a medical device & pharmaceutical manufacturer and distributor, is looking for a Director of Quality & Regulatory to help in our growing company. Forward Science, specializing in the oral care market, focuses on technologies for oral cancer and oral health. Forward Science has products that are quickly becoming standard of care in dental and medical offices nationwide. Forward Science is a young company with an innovative product pipeline and a great corporate culture.
Specific Tasks and Key Objectives:
- Serves as Head of Quality for organization
- Maintain oversight in:
- Complaint management
- Design changes and reviews
- Process changes
- Overseeing Document Control
- New product development
- Verification/Validation activities
- Risk Analysis
- Maintains product quality by enforcing quality assurance policies
- Prepares product and process quality reports by collecting, analyzing, and summarizing information and trends.
- Oversee the compliance and administration of R&D's Deviation/Investigation/CAPA management processes, ensuring timely closure and effectiveness.
- Prioritize quality actions and communicate up, down, and across the organization.
- Stays abreast of regulatory bodies’ regulations
- Interact with FDA and other regulatory bodies
- Write 510(k)s and other applications
- Provide subject matter expertise as during applicable regulatory inspections, presenting to, and interacting with inspectors as necessary.
3. Other Responsibilities
- Will be hands-on – Expectations are that candidate will be involved in drafting, editing, and completing documentation.
- The candidate will interface with Sales & Marketing regarding updates and timings of various new and existing products.
- The candidate may be involved in BizDev and other related activities.
- Bachelor’s Degree required. Advanced degree preferred
- Minimum of 10 years of Quality or Compliance experience in the medical device and/or pharmaceutical field
- The exceptional candidate will have experience in the Quality and Regulatory aspect of development and manufacturing
For the right candidate, there will be an opportunity for growth in compensation and responsibilities.
If you are interested, please submit your resume to Jobs@ForwardScience.com. Thanks, and we look forward to hearing from you!