Director of Regulatory Affairs
Location
Marlborough, MA | United States
Job description
Job Description
IPG Photonics is revolutionizing the laser industry as the pioneering developer and leading producer of fiber lasers and amplifiers. Headquartered in Marlborough, MA, IPG has over 6,500 employees in more than 30 locations around the world. We aspire to work together with our employees and customers to apply light in ways that improve life.
Our mission is to develop innovative laser solutions to make the world a better place. To accomplish this mission, we are committed to attracting and retaining the best talent and an engaged, diverse, and thriving workforce that drives a sustainable future for our company and society.
Working at IPG Photonics you can expect challenging projects, a motivating and friendly environment, and competitive benefits.
Job Summary 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. The Director of Regulatory Affairs is responsible for activities to lead and maintain global regulatory approvals to market devices throughout the product development lifecycle.
Job Functions - Develop strategies for regulatory approval of medical devices worldwide based on business needs;
- Organize project teams, initiate project schedules, and provide project leadership worldwide to achieve desired regulatory outcomes within defined timeframes;
- Prepare global regulatory applications, including U.S. Medical submissions (pre-submissions, 510ks, IDEs, and annual reports), EU MDR, and design dossiers and/or technical files for other international markets, such as India, China Southeast Asia, and Latin America; maintain regulatory files as required by departmental procedure;
- Interact with the U.S. FDA and other regulatory authorities worldwide;
- Manage reporting to the FDA (MDRs) and Vigilance Reports; participate in Complaint System;
- Review device labeling (including IFU) and advertising materials for compliance with global regulations; analyze and recommend appropriate changes;
- Participate in Risk Management assessments;
- Review design and manufacturing changes for compliance with applicable regulations;
- Oversee and prepare documentation to support the Clinical Evaluation Report to ensure accuracy, applicability, consistency, and control of regulatory documents;
- Support quality system audits by notified bodies, government agencies and customers;
- Assist with environmental regulations and standards (e.g., RoHS, REACH, etc.);
- Hire, mentor, and train regulatory staff; engage outside contractors, as needed;
- Perform all other essential duties as assigned.
Requirements - 10+ years of regulatory experience with US and international submissions of electro-mechanical and sterile medical devices;
- Demonstrated aptitude for preparing and submitting 510(k)'s and international design dossiers for new products;
- Prior interaction with the FDA and other worldwide agencies is required;
- Hands-on knowledge of all phases of Design Controls and Risk Management practices, regulations and standards, including FDA QSR's, ISO 13485, 14971, 10993, 11607, 14644, 14698, 15223, 11135, 11138, 11737, 17665, and 22442, and IEC 60601, 60825, 62304, and 62366;
- Experience in building and managing regulatory teams; leading cross-functional project teams on collaborative projects;
- 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 - High level of attention to detail and organization skills;
- Strong oral, written, and interpersonal skills;
- Must be able to interact with customers and suppliers;
- Ability to link functional responsibilities to overall business goals and to manage multiple projects simultaneously.
- Work well under pressure to meet deadlines.
Ability to work well under pressure and handle multiple projects and meet deadlines.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:
Job tags
Salary
