The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
Support global regulatory submissions and ongoing regulatory compliance through the product development lifecycle.
Prepare global regulatory applications, including U.S. Medical submissions (Pre-Submissions, 510ks, IDEs and applicable supplements and annual reports), Canadian Class 2 Device License submissions, EU MDR Submissions, and other international markets such as Japan, the Far East, Australia and Latin America;
Review device labeling (including IFU) and advertising materials for compliance with global regulations; analyze and recommends appropriate changes;
Participate in Risk Management assessments;
Review design and manufacturing changes for compliance with applicable regulations;
Support quality system audits by notified bodies, government agencies and customers;
Assist with environmental regulations and standards (e.g. RoHS, REACH, etc.);
Maintain regulatory files as required by departmental procedure;
Perform all other essential duties as assigned.
3-10 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.
Bachelor’s degree, preferably in an engineering or life sciences discipline;
Masters in Regulatory Affairs or Regulatory Affairs Certification (RAC) is a plus.
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
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.
Internal Number: 21-101
About IPG Medical
The medical community continues to show an increased demand for lasers in diagnostic, therapeutic and surgical applications. In cosmetic/therapeutic dermatology, from skin rejuvenation (stimulating collagen growth) and vascular treatment to skin, hair, fat and tattoo removal, fiber laser technology improves the treatment outcomes, lowers the cost of treatment and provides faster treatment with shorter recovery times. From urology to ophthalmology, surgical applications demand laser-based solutions with precisely controlled parameters and excellent beam quality. In dentistry, lasers are being adopted for bone and gum regeneration, soft tissue, hard tissue and root canal surgery, fast whitening and pain treatment.
IPG provides a very broad range of laser sources for integration into medical devices including diode lasers, ytterbium lasers near 1 ?m, erbium lasers near 1.5 ?m, and thulium CW fiber lasers near 2 ?m, QCW ytterbium and thulium fiber lasers, CW green and ns pulsed green lasers, hybrid fiber-pumped lasers in the mid-infrared (IR) range, Raman fiber lasers (in infrared and visible ranges) and pico and femtosecond pulsed lasers at 1 and 1.5 ?m.