Senior Regulatory Affairs Specialist

Company: Formlabs
Location: Somerville
Posted on: May 18, 2023

Job Description:

To reinvent an industry, you have to build the best team. Join Formlabs if you want to bring ground-breaking professional 3D printers and materials to the desktop of medical and dental professionals all over the world.
We are looking for someone to join the Regulatory Team and ensure Formlabs products comply with regulatory standards as we bring new products into markets across the globe. -Are you excited to take the next step in a fast growing company and put your regulatory and project management skills to work? If so, we want you to join as our Sr. Regulatory Affairs Specialist. This role may report into either our Somerville, MA or Toledo, OH office.
The Job:

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• 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
  
  You:
  
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  • 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
    
    Bonus Points:
    
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    • Experience working with additive manufacturing
      
    • RAC or project management certification
      
      Our Perks:
      
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      • Robust equity program to build future wealth through RSUs
        
      • Comprehensive healthcare coverage (Medical, Dental, Vision)
        
      • Low cost fund options in our 401K and access to advisors -
        
      • Generous paid Parental Leave (up to 16 weeks)
        
      • Tenure-based paid Sabbatical Leave (up to 6 weeks)
        
      • Flexible Out of Office Plan - Take time when you need it
        
      • Ample on-site parking & pre-tax commuter benefits
        
      • Healthy on-site lunches, snacks, beverages, & treats
        
      • Regular sponsored professional development opportunities
        
      • Many opt-in culture events across our diverse community
        
      • And of course--- 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.
        To all recruitment agencies: Formlabs does not accept agency resumes. Please do not forward resumes to our jobs alias, Formlabs employees or any other company location. Formlabs is not responsible for any fees related to unsolicited resumes. Unsolicited resumes received will be considered our property and will be processed accordingly.

Keywords: Formlabs, Somerville , Senior Regulatory Affairs Specialist, Other , Somerville, Massachusetts