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Sr Regulatory Affairs Specialist #21-101
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 Senior Regulatory Affairs Specialist, 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. The Senior Regulatory Affairs Specialist will report to the Director of QA and Regulatory Affairs.
- Independently 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
- 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.
- 5+ years’ of experience with US and EU regulatory preparations and submissions of Class II electro-mechanical medical devices
- Hands-on knowledge in preparing and submitting Clinical Evaluation Reports, Medical Device Regulation submissions, 510K preparations and submittals, ongoing reporting to Medical Device regulatory agencies and knowledge of other international regulatory requirements.
- Familiarity with medical device design and manufacturing in an ISO 13485 / FDA CFR 820 environment.
- Experience with Complaint management and Regulatory reporting requirements for medical devices in the US and EU.
- 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.
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Job posted: 2022-08-04