Quality and Regulatory Affairs Lead
Location: Somerville, MA
As a leader in 3D printing technology, Formlabs is reinventing the digital manufacturing industry. This mission takes innovation, persistence, and building the best team of people to make it happen. Join Formlabs if you want to bring groundbreaking professional 3D printers and materials to the desktop of medical and dental professionals all over the world.
Our Product and Manufacturing teams are looking for someone to help Formlabs products comply with regulatory standards as we develop new technologies and expand to markets across the globe. Are you excited to take a leadership role within the product lifecycle and put your regulatory, quality, and project management skills to work? If so, we want you to join us as our Quality and Regulatory Affairs Lead.
- Employ excellent risk assessment and management skills to communicate clearly and effectively across multiple channels (including regulatory agencies, sales partners and internal product and manufacturing teams)
- Perform technical, scientific and regulatory activities to support both domestic and international/multinational issues
- Participate in activities spanning the product life-cycle (tackling business, management and strategy needs)
- Establish the procedure for the development and rollout of new materials (Class I and II), with regulatory timelines in mind
- Solid regulatory and compliance knowledge regarding submissions and agency interactions
- Experience with medical device development in an international work environment
- Extensive experience in a comparable position in the healthcare industry, academia or scientific discipline
- Focused, with the drive to set and stick to deadlines
- Well-versed in manufacturing best practices
- Solid understanding of current FDA practices in class I and class II categories
- RAC certification
- Interest in 3D printing
- Flexible Vacation
- Generous premium coverage for medical, dental, and vision plans
- Paid parental leave
- Commuter benefits
- Unlimited 3D prints
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. Even if you don't check every box, but see yourself contributing, please apply. Help us build an inclusive community that will change the face of 3D printing.