Experience Desired: - 5-10 years of experience with US and EU regulatory preparations and submissions of Class II electro-mechanical medical devices;
- Hands-on knowledge of all phases of Design Controls and Risk Management practices, regulations standards, such as FDA QSR's, ISO 13485, ISO 14971, IEC 60601, 60825, and 62366;
- Strong working knowledge of Microsoft Word and Excel.
Education Required: - Bachelor’s degree, preferably in an engineering or life sciences discipline;
- Masters in Regulatory Affairs or Regulatory Affairs Certification (RAC) is a plus.
Personal Requirements: - Excellent oral, written, and interpersonal skills;
- Must be able to interact with customers and suppliers;
- Ability to work in a cross-functional environment with competing priorities;
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 to request assistance. Please note that only those inquiries concerning a request for reasonable accommodation will be responded to. |
