Jacobs Management Group, Inc.

Director, Regulatory Affairs – Compliance Systems & Labeling

Jacobs Management Group, Inc.  •  $197k - $246k/yr  •  Lakewood, CO (Hybrid)  •  3 months ago
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Job Description

Step into a high-impact leadership role shaping global regulatory strategy for life-sustaining blood and cell technologies. My client is seeking a visionary regulatory leader to champion compliance systems, elevate global labeling strategy, and guide complex submissions that directly impact patients worldwide. This is your opportunity to influence executive decisions and drive a culture of quality across the full product lifecycle.

Why You Should Apply

  • $196,500 – $245,600 base salary + 30% target bonus
  • Executive-level visibility with influence across global business units
  • Lead regulatory strategy for innovative medical device and combination products
  • Hybrid onsite role in Lakewood, CO with global scope and 10–15% international travel
  • Comprehensive medical, dental, vision, 401(k) match, wellness programs, and robust total rewards

What You’ll Be Doing

  • Direct global regulatory affairs and labeling strategy
  • Oversee 510(k), PMA, IDE, CE Mark, NDA/ANDA and international submissions
  • Serve as primary interface with global regulatory authorities
  • Lead compliance programs including UDI and regulatory operations
  • Partner cross-functionally with R&D, Clinical, Quality, Legal, Manufacturing, and Marketing
  • Act as PRRC and champion a culture of quality and compliance
  • Guide and develop a high-performing regulatory team

About You

  • Be able to do the job as described.
  • Deep experience with both sterile disposables and electro-mechanical devices with embedded software
  • Proven success representing novel technologies to regulatory authorities and securing approvals
  • Expertise across US, EU, and Canada regulatory frameworks
  • Experience with drug/device combination products and PRRC responsibilities
Jacobs Management Group, Inc.

About Jacobs Management Group, Inc.

Celebrating over 30 years in business, Jacobs Management Group, Inc. is one of the top boutique executive search firms with a specialty focus in the healthcare (pharmaceutical, medical device, biotechnology, diagnostics) and high-tech industries, nationally.

Looking to hire your next team member or seeking your next opportunity? Our full service recruiting team can help.

A Bit More About Us!

Having been in the industry for what seems like forever, we have built a database of over 300,000 candidates and we continually expand it every day. We have followed their careers building long-standing relationships because we know their interests and desired future steps, and present them with targeted opportunities. Building lasting trust-based relationships is the goal of our entire organization.

This pre-built network allows us to quickly connect our clients with exceptional industry talent. We leverage our wealth of Executive Recruiting experience to ensure you see only the highest caliber of talent specifically matched to your needs. Our team approach to each assignment helps us complete each engagement in a record time. We are known for introducing you to a small slate of targeted candidates. Oftentimes, our clients have trouble choosing just one candidate, and find a way to add another position because they see such highly skilled talent

Industry
HR & Recruiting
Company Size
51-200 employees
Headquarters
Philadelphia, Pennsylvania
Year Founded
1988
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