Director, Regulatory Affairs – Compliance Systems & Labeling
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Job Location:
Lakewood, CO - USA
Monthly Salary:
$ 196500 - 245600
Posted on:
14 hours ago
Vacancies:
1 Vacancy
Job Summary
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
- $196500 $245600 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 1015% international travel
- Comprehensive medical dental vision 401(k) match wellness programs and robust total rewards
What Youll 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
Required Experience:
Director
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
Niche executive search firm with 30+ years specializing in executive search and staffing in Medical Device, Biotech, Pharma, and Diagnostics. Jacobs Management Group is a WBENC certified retained and contingent search firm with 30+ years of industry success and a national network.
