Director of Regulatory Affairs #23-528

Regulatory Affairs Manager at IPG Medical

IPG Medical, a wholly-owned subsidiary of IPG Photonics (NASDAQ: IPGP), is actively seeking a highly motivated Regulatory Affairs professional to join our growing team. As the Regulatory Affairs Manager, you will play a crucial role in supporting global regulatory submissions and ensuring ongoing compliance throughout the product development lifecycle. This opportunity is ideal for a candidate with strong attention to detail and in-depth knowledge of the regulatory applications process for Class II medical devices.

Responsibilities

Developing Strategies:

• Develop strategies for regulatory approval of medical devices worldwide based on business needs.

Project Management:

• Organize project teams, initiate project schedules, and provide project leadership worldwide to achieve desired regulatory outcomes within defined timeframes.

Regulatory Applications:

• 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 international markets (India, China, Southeast Asia, Latin America); maintain regulatory files as required.

Interactions and Reporting:

• Interact with the U.S. FDA and other regulatory authorities worldwide.
• Manage reporting to the FDA (MDRs) and Vigilance Reports; participate in Complaint System.

Compliance and Reviews:

• 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.

Documentation and Support:

• Oversee and prepare documentation to support the Clinical Evaluation Report to ensure accuracy, applicability, consistency, and control of regulatory documents.

Quality System and Audits:

• Support quality system audits by notified bodies, government agencies, and customers.

Additional Responsibilities:

• 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

Experience:

• 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.

Knowledge:

• 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.

Skills:

• Experience in building and managing regulatory teams; leading cross-functional project teams on collaborative projects.
• Strong working knowledge of Microsoft Word and Excel.

Education:

• 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 organizational skills.
• Strong oral, written, and interpersonal skills.
• Ability 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.

Note: 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 a person from Country Group B.

The following link will take you to the government site with the list of Country Group B: Country Group B List

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