Senior Regulatory Affairs Specialist - IPG Photonics
Marlborough, MA 01752
About the Job
Thank you for your interest in positions at IPG Medical Group. All applicants must apply on our company website to be considered. Please visit www.ipgphotonics.com and click on the “Company” tab. We look forward to seeing your application soon!
IPG Medical Corporation is focused on developing next-generation medical products based on its state-of-the-art technology. Headquartered in Marlborough, MA, we aspire to work together with our employees and customers to apply light in ways that improve life.
IPG Medical Corporation is focused on developing next-generation medical products based on its state-of-the-art technology. Headquartered in Marlborough, MA, we aspire to work together with our employees and customers to apply light in ways that improve life.
Our mission is to develop innovative medical device laser solutions that 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 Medical Group you can expect challenging projects, a motivating and friendly environment, and competitive benefits.
The ideal candidate is a diligent, hardworking individual who is willing and able to learn new skills and technologies to ensure the IPG Medical team achieves its mission.
Job Summary:
The ideal candidate is a diligent, hardworking individual with 2 to 5 years of regulatory experience post internship/post graduate in a medical device environment, who has the ability to learn new skills and technologies. In this position you will be given the opportunity to grow in the regulatory field and ensure the IPG Medical team achieves its mission. The Regulatory Affairs Specialist will work closely with the Director of Regulatory Affairs to obtain and maintain global regulatory approvals to allow IPG to market its state of the art devices worldwide.
Duties/Responsibilities:
- Prepare and submit global regulatory applications, including U.S. Medical submissions (Pre-Submissions, 510ks, IDEs and applicable supplements and annual reports), Canadian Class 3 Device License submissions, EU MDR Submissions, and other international markets such as Japan, Saudi Arabia, Australia and Brazil.
- Review device labeling (including IFU) and advertising materials for compliance with global regulations; analyze and recommends appropriate changes.
- Assess design and manufacturing changes for compliance with applicable regulations and effect on registrations.
- Maintain regulatory files and tracking databases as needed.
- Support quality system audits by notified bodies, government agencies and customers.
- Obtain Medical Device Certificates to Foreign Government (CFGs).
- Support post market surveillance, including preparation of post market clinical follow up plans and reports. Participate in the review of complaints and all other post market-release feedback.
- Submit medical device reports. Support Unique Device Identifier activities.
REQUIRED QUALIFICATIONS:
- Bachelor’s degree or equivalent work experience, preferably in an engineering or life sciences discipline.
- 2-5 years of post-internship/post graduate experience with regulatory submissions and management of Class II electro-mechanical medical devices.
- Regulatory affairs experience in generating applications and experience in collaboration with internal and external partners to answer any subsequent questions.
- Knowledge of Design Controls and Risk Management practices, regulations and standards, such as FDA QSR's, ISO 13485, ISO 14971, IEC 60601, 60825, and 62366.
- Experience with lasers and optical technologies desired, but not necessary.
- Strong working knowledge of Microsoft Word and Excel.
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.
Source : IPG Photonics