Regulatory Compliance Specialist (22-643)

Full Time
Oxford, MA 01540
Posted
Job description
Thank you for your interest in positions at IPG Photonics. All Applicants must apply on our company website to be considered. Please click here to apply directly: https://recruiting.adp.com/srccar/public/RTI.home?c=2179707&d=ExternalCareerSite&r=5000908381806&_fromPublish=true#/

Regulatory Compliance Specialist will have responsibility for supporting and maintaining regulatory compliance for new product development and existing products. Emphasis on regulations including FDA/CDRH Laser product, CE, ROHS, REACH, WEEE, CSA, EPA TSCA compliance is key. Regulatory Compliance Specialist will report directly to QA Manager.

Responsibilities:
  • Collect, analyze, and interpret environmental data to assess risk and evaluate compliance
  • Prepare and submit all required environmental compliance reports to the relevant stakeholders
  • Interface with regulatory authorities to oversee regulatory audits/inspections
  • Facilitate third-party laboratory evaluations to achieve product environmental compliance
  • Identify, analyze, and track new and emerging environmental regulations, including participation in legislative development
  • Implement and improve programs and procedures to manage and sustain compliance certifications and registrations
  • Create CDRH Reports for new laser products
  • Create CDRH annual reports for all IPG Photonics laser products
  • Support Importing of Laser products coming into USA
  • Educate others in area of Regulatory Compliance

Requirements:
  • Minimum Bachelor’s Degree in Environmental, Chemical, Environmental Science or a closely related engineering discipline; or equivalent in experience
  • Three or more years of experience working in environmental compliance programs
  • Strong technical knowledge and skills implementing and complying with REACH Regulation, WEEE Directive, RoHS Directive, and EPA TSCA regulations
  • Knowledge of FDA/CDRH is a plus but not required
  • Demonstrated experience taking products through the certification process

This position must meet Export Control compliance requirements, therefore a “US Person” as defined by 22C.F.R. §120.15 are required. “US Person” includes US Citizen, lawful permanent resident, refugee, asylee. License exception Technology and software under restriction (TSR) defined in 15 CFR 740.6 may permit person from Country Group B.
The following link will take you to the government site with the list of Country Group B: https://www.bis.doc.gov/index.php/documents/regulation-docs/452-supplement-no-1-to-part-740-country-groups/file
Equal Opportunity Employer / Affirmative Action M/F D/V
IPG Photonics Corporation is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. All employment decisions and personnel actions at IPG Photonics are administered without regard to race, color, religion, creed, national origin, ancestry, sex, age, qualified mental or physical disability, gender identity, sexual orientation, genetic carrier status, any veteran status, any military service, any application for any military service, or any other category or class protected by applicable federal, state or local laws. IPG Photonics Corporation provides reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Assistance Act of 1974 and Title I of the Americans with Disabilities Act of 1990. Applicants who need accommodation in the job application process should contact (508) 506-2527 or email HR.Accommodations@ipgphotonics.com opens an email client applicationto request assistance. Please note that only those inquiries concerning a request for reasonable accommodation will be responded to.

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