Medical Program Manager (23-381)

IPG Medical, a wholly owned subsidiary of IPG Photonics (NASDAQ: IPGP), is seeking a highly motivated and experienced Regulatory Affairs professional to join our growing company. As a Regulatory Affairs Manager, you will be responsible for supporting global regulatory submissions and ongoing regulatory compliance through the product development lifecycle. This role would be a great opportunity for someone who is looking to take the next step in his or her career and requires strong attention to detail, as well as comprehensive knowledge of the regulatory applications process for Class II medical devices.

The ideal candidate is a diligent, hardworking individual with significant regulatory experience, who is willing and able to learn new skills and technologies to ensure the IPG Medical team achieves its mission.

Job Functions

Responsible for managing large-scale, highly complex, multi-faceted new medical product development programs, involving internal and external development partners.Provides technical leadership in design, test and system integration of medical devices and instruments.Plans of all program subsystem and project deliverables.Formulates and gains approval for overall project plans in consultation with senior management and stakeholders.Proactively identify and assess areas of risk, escalate issues in a timely manner and proactively propose solutions.Partners with development team members to drive accountability and high quality of project tasks and deliverables. Continuous prioritization of team member activities and follow up on actions.Manages program budgets, generates forecasts, and tracks actuals against forecasts.Monitors progress to plan and implements corrective actions or contingencies as needed to maintain commitments.Provides management with regular project status, variances to plan, and identification of corrective actions.Works closely with functional management to gain resource commitments and resolve issues.Provides input to directors/managers and senior management on team member performance. Effectively manages performance issues and conflicts.Oversees and facilitates compliance to design control and product development processes.Ensures project team activities and decisions are clearly communicated and documented.

Requirements

Prior Med Device experience a must. Laser experience a plus.BS degree (MS preferred) in an Engineering discipline.Advanced skills in project management, projects reporting and presentations.Excellent written and verbal communication skills.5+ years project management experience of complex laser-based systems.10+ years technology development experience in one of the following areas: lasersystems, electro-opto-mechanical systems, optics-based medical devices.Track record of executing complex multi-functional project on time and within budget.Ability to manage multiple projects in a fast-paced development environment.Proven experience working within controlled product development process.Knowledge of Design Controls and Risk Management practices, regulations and standards, such as FDA QSR's, ISO 13485, EU MDR, ISO 14971, IEC 60601, 60825, and 62366, is preferred.

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. 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/VIPG 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.