Quality and Regulatory Affairs Lead

| Somerville

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 to the desktop of every designer, engineer, researcher, and artist in the world and beyond.

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 life cycle and put your regulatory, project management, and strategy development skills to work? If so, we want you to join us as our Quality and Regulatory Affairs Lead.

The Job:

  • 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 procedure for the development and rollout of new materials, with regulatory timelines in mind

You:

  • Experience with medical device development
  • Extensive experience in comparable position in the healthcare industry, academia or scientific discipline
  • Proven manager with experience in budget preparation
  • Focused, with the drive to set and stick to deadlines
  • Excellent technical and leadership skills
  • Well-versed in manufacturing best practices
  • Solid regulatory knowledge regarding submissions and agency interactions

Bonus:

  • RAC certification
  • Interest in 3D printing

Our Perks:

  • 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.

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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!

Formlabs

Formlabs

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?

Everything Formlabs is doing and creating has never been done before. We are a work-in-progress organization with a lot of space for growth. We seek to cultivate an environment where individuals can contribute their own new ideas and participate in the evolution of the company.

Formlabs

Formlabs

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 . . .

Formlabs

Formlabs

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.

Health Insurance & Wellness Benefits
Flexible Spending Account (FSA)
Dental Benefits
Vision Benefits
Health Insurance Benefits
Retirement & Stock Options Benefits
401(K)
Company Equity
Child Care & Parental Leave Benefits
Generous Parental Leave
Flexible Work Schedule
Vacation & Time Off Benefits
Unlimited Vacation Policy
Perks & Discounts
Beer on Tap
Casual Dress
Company Outings
Game Room
Stocked Kitchen
Some Meals Provided
Happy Hours
Pet Friendly
Recreational Clubs
Fitness Subsidies

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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