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Sr. Regulatory Affairs Engineer

Employer
Stratasys
Location
Eden Prairie
Salary
Competitive

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LOCATION: Eden Prairie, MN

Make it first; make it better. As the original 3D pioneers with a track record of firsts over 30+ years, we have defined our industry and shaped the development of 3D printing since the beginning. Today, we invest in our people and our technology to ensure that we continue to lead the industry with the next generation of 3D innovation - setting new standards for speed and accuracy. We aim to recruit the very best to help us create new 3D solutions that will shape the future - improving it for millions of people worldwide. We believe in leading from the front.

Stratasys is currently seeking a Regulatory Affairs Materials Engineer to join our Eden Prairie Operations department. This position is responsible for the compliance and surveillance of materials portfolio including: products environmental compliance such as but not limited to ROHS, REACH, TSCA, PROP 65, SVHC lists, Additionally, provide tactical direction and field support for chemicals compliance discipline for all the products, administration of materials compliance.

Regulatory Compliance

* Will direct activities and assist with interactions during regulatory agency inspections, audits and examinations.
* Will establish and monitor resulting CAPAs are completed.
* Will direct interactions with regulatory agencies on defined matters to include but not limited to: ROHS, REACH, TSCA, PROP65, SVHC lists, chemical waste disposal, wastewater protocols, chemical emissions, medical certifications, food contact approvals, and transportation of chemicals.
* Provide direction and field support for chemicals compliance discipline for all the products, stewardship and administration of materials compliance to meet all global regulation standards.
* Partner with legal in filing and compliance on regulatory programs to report to senior leadership.
* TSCA FC and perform and maintain a compliance verification to confirm that any new and existing products are TSCA compliant prior to its import.
* Working with external bodies on requirements for TSCA and other regulatory requirements to map the needs on the materials at a corporate program.

Regulatory Product Support

* Partner with business units to monitor, report on compliance matters and regulatory affairs.
* Generate/gather necessary documentation to support certifications and submit to the certifying laboratory/organization.
* Identify and support external/internal laboratory testing process to meet relevant certifications.
* Perform product reviews and respond to inquiries about product compliance.
* Coordinate and participate with business unit R&D teams on design for compliance to the relevant standards.
* Assess materials regulatory requirements and implement programs to ensure products compliance.
* Initiate, maintain and renew food contact / bio compatibility / other certificates and reports
* Work with functional departments to react to upcoming changes without interruption to certifications.
* Manage materials data information in the various company databases, issue ECO's, document and manage product chemical compliance data with regulatory team.

Minimum Qualifications

* Must be Export Control Compliant (ITAR) ??? Yes ???No
* 10+ years industry experience in regulatory compliance is required.
* 8+ years' experience applying- REACH, TSCA, Prop. 65, K-REACH, Reporting and certifications
* Proficient experience working with regulatory bodies on a global basis.
* Proficient experience in enforcing the regulatory rules.
* Proficient to investigate, audit and interview to unravel hidden records of the company.

Preferred Qualifications:

* Experience in formulations development
* Prior experience in the additive manufacturing and/or printing industry.

TRAVEL REQUIREMENT: 25%

For over 30 years we've been pioneering 3D Printing technology, solving problems, questioning, inventing and reinventing. Continually asking, "How can we help our customers turn a great idea into a great success?".

It's what drives us. Because we want our customers to succeed.

We provide the best products, services and support great thinking deserves.

Giving your ideas the best possible chance of making it. Make it better. Make it with Stratasys.

Stratasys (Nasdaq: SSYS), headquartered in Minneapolis, Minnesota and Rehovot, Israel, is a leading global provider of 3D printing and additive manufacturing solutions. The company's patented FDM?? and PolyJet??? 3D Printing technologies produce prototypes and manufactured goods directly from CAD data for the aerospace, automotive, healthcare, consumer goods and education industries. Stratasys subsidiaries include MakerBot and GrabCAD, and the company operates the digital parts manufacturing service, Stratasys Direct. Stratasys has over 2,000 employees, holds over 1,200 granted or pending additive manufacturing patents globally, and has received more than 30 awards for its technology and leadership.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Stratasys will provide reasonable accommodations for qualified individuals with disabilities. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.

Stratasys is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to their protected Veteran or disabled status and will not be discriminated against for their race, color, religion, sex, age, disability, military status, or national origin or any other characteristic protected under federal, state, or applicable local law. Please view Equal Employment Opportunity Posters provided by OFCCP here.

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