Senior Director of Regulatory Affairs
Real Staffing, Chicago, IL, United States
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.
To find out more about Real, please visit www.realstaffing.com
#J-18808-Ljbffr
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.
To find out more about Real, please visit www.realstaffing.com
#J-18808-Ljbffr