Senior Director of Regulatory Affairs

Overview

I'm working with a global medical device organization in Chicago that is looking to hire a Senior Director, Regulatory Affairs. Your background stood out, and I thought this may align well with your experience. This role leads global regulatory strategy across a broad portfolio of medical devices and infection‑prevention products. It's a highly visible position partnering with R&D, Quality, Product Management, and executive leadership to guide the organization through complex regulatory pathways and support ongoing innovation. Salary: $150,000 - $200,000

Responsibilities

• Lead global regulatory strategy for product development and lifecycle management
• Oversee FDA, EU MDR, Canadian MDL, TGA, NMPA (China), and other international submissions
• Act as primary liaison with global regulatory agencies
• Provide guidance to cross‑functional teams to ensure compliance
• Monitor regulatory landscape and assess business impact
• Manage and mentor a global regulatory team
• Lead audit/inspection readiness and response
• Oversee vigilance and medical device reporting
• Ensure product claims, labeling, packaging, and advertising meet regulations

Minimum qualifications

• Bachelor\'s degree in life sciences, engineering, or related field
• 10+ years of regulatory affairs experience in medical device, biotech, or pharma
• Proven experience leading FDA and international submissions
• Strong knowledge of U.S. and EU regulatory frameworks
• Leadership experience managing regulatory teams

Preferred qualifications

• Advanced degree (MS, MBA, etc.)
• Experience with global regulatory environments and multiple product lines
• Strong project management skills and familiarity with electronic submission systems

If you\'re open to exploring this opportunity, I\'d be happy to share more details. Would you be open to a quick conversation?

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

In addition to base pay, direct-hire employees may be eligible for client offered benefits such as medical, dental, and vision coverage, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.

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