Regulatory Affairs Manager jobs in Worcester, MA

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

• 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.