Regulatory Affairs Lead at Formlabs

| Somerville
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To reinvent an industry, you have to build the best team. 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.

We are looking for someone to lead and grow 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 a leadership role in a fast growing company and put your regulatory, quality, and management skills to work?  If so, we want you to join as our Regulatory Affairs Lead.  

The Job:

  • Lead Formlabs compliance strategies and regulatory activities; ensure business needs and regulatory initiatives are in alignment, and the company meets overall operational objectives. 
  • Liaise with regulatory bodies and third-party service providers to understand requirements for successful product submissions, clearances, and approvals for Formlabs products.
  • Responsible for regulatory submissions of Formlabs new or modified medical materials to FDA and other global regulatory bodies. 
  • Define and drive regulatory strategies for new product development; provide guidance for R&D, Sales, Marketing, and Manufacturing with the goal of commercializing Formlabs new medical & dental products. 
  • Lead and manage complex issues with multiple competing priorities that have a direct impact on operations and opportunities. Partner with other functional areas (including Manufacturing, Quality, Product, R&D, Marketing, Customer Service, Legal and Compliance) to deliver solutions and execute tactics that further business objectives in an effective and compliant manner.  
  • Continuously improve and monitor the quality management system to demonstrate compliance.  Identifying gaps in current operating model to improve overall efficiency and sophistication as the company matures.
  • Manage, coach and develop the Regulatory Team to ensure skills are aligned with a high performing organization.
  • Interact with outside consulting groups and vendors to manage activities necessary for completing key initiatives.

You: 

  • Have 7 or more years of relevant experience in regulatory functions. 
  • BA/BS in Life Sciences or a Healthcare related field is required.  
  • Have extensive experience in regulatory compliance relevant to medical devices.  A demonstrated track record of success in regulatory filings for US (510(k)) and other key countries/regions such as European Community (EC) MDR.  
  • Hold a broad knowledge of medical device operations and quality guidelines; working knowledge of ISO-13485 or other quality systems.
  • Are capable of strategic thinking and proposing innovative solutions to regulatory problems.  You are results oriented, with a strong sense of urgency and willingness to set and drive aggressive project timelines.
  • Have outstanding written and oral communication and negotiation skills. Ability to present and effectively communicate complex concepts to audiences of various backgrounds and knowledge levels.
  • Maintain a high level of personal and professional integrity with a strong work ethic and the ability to work independently with minimal direction.
  • Are know for your top-notch interpersonal, analytical, organizational, and leadership skills, and ability to stay up to date on current regulations.

Bonus:

  • Experience in 3D printing medical device regulations.
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Technology we use

  • Engineering
  • Product
  • Sales & Marketing
    • C++Languages
    • GolangLanguages
    • PythonLanguages
    • SqlLanguages
    • ReactLibraries
    • DjangoFrameworks
    • FlaskFrameworks
    • Node.jsFrameworks
    • IllustratorDesign
    • PhotoshopDesign
    • SolidWorksDesign
    • AsanaManagement
    • Google DriveManagement
    • JIRAManagement
    • DocuSignCRM
    • DriftCRM
    • LinkedIn SalesNavigatorCRM
    • OutreachCRM
    • SalesforceCRM
    • GongCRM
    • MarketoLead Gen

Location

35 Medford St. Suite 201, Somerville, MA 02143

An Insider's view of Formlabs

What’s the vibe like in the office?

Culture is extremely important at Formlabs. With now over 400 people combined in our Boston and Berlin offices, the goal is to “keep Formlabs weird,” which is really just a fun way of saying, “let’s keep things interesting.” Since we are trailblazing the way for a new era of low-cost manufacturing, keeping things interesting isn’t too difficult!

Meagan

Rebelo

What projects are you most excited about?

Everything we produce is an ongoing project. A big focus for us has always been to relentlessly improve upon our existing products. We release regular updates to our software, printer and materials - keep an eye on our blog to see all the exciting things we have planned for the coming year!

Formlabs

Formlabs

How does the company support your career growth?

Formlabs has a fairly flat organizational structure, so there is a relatively low barrier to taking on projects outside of your job scope and trying to grow into a new role.

Annie

Hughes

What is your vision for the company?

We're committed to bringing powerful and accessible fabrication tools into the creative hands of professionals around the world.

Formlabs

Formlabs

What are some social events your company does?

We regularly have people organizing everything from whiskey tastings to ice climbing. The interest-diversity here is vast and people are quick to jump in and learn something new. Just to name a few of our internal “clubs," we have Booklabs, Filmlabs, Whiskeylabs, ping pong tournaments, Fitness Bootcamp, yoga, Ragnar, summer camps, hackathons . . .

Alyce

Currier

What are Formlabs Perks + Benefits

Formlabs Benefits Overview

We invest in our people. That's why we provide flexible vacation, generous premium coverage for medical, dental, and vision plans, paid parental leave, commuter benefits, and unlimited 3D prints. We are committed to offering a holistic benefit package to support you inside and outside the office.

Culture
Eat lunch together
Diversity
Dedicated Diversity/Inclusion Staff
Diversity Employee Resource Groups
Health Insurance & Wellness Benefits
Flexible Spending Account (FSA)
Dental Benefits
Vision Benefits
Health Insurance Benefits
Life Insurance
Inclusive of expandable partner benefits
Wellness Programs
Retirement & Stock Options Benefits
401(K)
Company Equity
Child Care & Parental Leave Benefits
Generous Parental Leave
Flexible Work Schedule
Family Medical Leave
Company sponsored family events
Vacation & Time Off Benefits
Unlimited Vacation Policy
Generous PTO
Paid Holidays
Paid Sick Days
Perks & Discounts
Beer on Tap
Casual Dress
Commuter Benefits
Company Outings
Free Daily Meals
Game Room
Stocked Kitchen
Some Meals Provided
Happy Hours
Parking
Pet Friendly
Recreational Clubs
Relocation Assistance
Fitness Subsidies
Professional Development Benefits
Job Training & Conferences
Diversity Program
Promote from within
Online course subscriptions available

Additional Perks + Benefits

Catered lunches 3x per week, unlimited snacks, office pets, 100% healthcare coverage, regular presentations and technical talks, Form Clubs for anything and everything.. CoffeeLabs, WhiskeyLabs, PaintLabs, GameLabs, FilmLabs, the list goes on. A culture that welcomes you into your FormFamily from Day One.

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