Senior Regulatory Affairs Specialist
Posted on 3/9/2023
Cambridge, MA, USA
- Expand the global reach of our medical devices by supporting regulatory market access around the world through timely strategy and project execution
- Prepare various regulatory submissions for registering and certifying products globally to ensure Formlabs' products can reach our customers and patients around the world
- Provide regulatory direction to project teams for product development/design control related activities
- Maintain a working knowledge of existing and proposed regulations, standards and guidance documents, internal procedures, and facility registration, device listing and import/export requirements
- Lead regulatory initiatives and drive process improvement to maintain compliance and drive efficiency
- BA/BS in engineering, life sciences or healthcare related fields is required
- 5+ years of relevant medical device regulatory experience bringing products to multiple geographies
- Strong working knowledge of global regulations (US FDA, EU MDR, Canadian MDR) and industry standards (ISO 14971, ISO 13485) consistent with requirements for a manufacturer of globally distributed medical devices
- Capable of strategic thinking and proposing innovative solutions to regulatory problems. Results oriented, with a strong sense of urgency and willingness to set and drive aggressive project timelines
- Outstanding written and oral communication and negotiation skills. Ability to present and effectively communicate complex concepts to audiences of various backgrounds and knowledge levels
- High level of personal and professional integrity with a strong work ethic and the ability to work independently with minimal direction
- Experience working with additive manufacturing
- RAC or project management certification
Advanced 3D printing systems
Formlabs is reinventing 3D printing by expanding access to digital fabrication, so anyone can make anything.
- Flexible vacation
- Premium coverage for medical, dental, and vision plans
- Paid parental leave
- Commuter benefits
- Unlimited 3D prints
Company Core Values
- Autonomy: We leave space for people to do their best, and take initiative to chart their own career course.
- Cutting Edge: We’re building things that haven’t been built before, so we can push the edge of what’s possible.
- Results: We dream big, but our focus on getting things done is what drives us forward.
- Curiosity: We are always asking why to push ideas and actions beyond the status quo.