Regulatory Affairs Director — Personalized Medical Devices

Morgan Stanley; Littleton (CO); On-site; USD 177,000 - 266,000; Full time

Benefits offered by this job

Competitive Pay: $177,000–$266,000 annually

Paid Leave

401(k) with employer matching

Comprehensive Health & Wellness Plans

Job summary

Morgan Stanley is looking for a candidate for a pivotal leadership role in regulatory strategies for personalized healthcare in Littleton, Colorado. The successful candidate will manage a team, drive regulatory excellence, and ensure compliance within a dynamic environment.

You will lead regulatory submissions and interact with senior leadership to inform product development and market access, significantly impacting patient access to innovative therapies.

Qualifications

• 12+ years of progressive Regulatory Affairs experience with 5+ years in the medical device industry.
• Strong knowledge of FDA and EU MDR regulatory frameworks.
• Proven ability to prioritize competing demands.

Responsibilities

• Define and execute global regulatory strategies.
• Lead the planning and submission of regulatory filings.
• Act as a key advisor to senior leadership on regulatory insights.

Skills

Regulatory expertise

Leadership and team management

Communication and influence

Problem-solving

Education

Bachelor’s degree in Life Science

Regulatory Affairs Certification (RAC)

Job description

Morgan Stanley is looking for a candidate for a pivotal leadership role in regulatory strategies for personalized healthcare in Littleton, Colorado. The successful candidate will manage a team, drive regulatory excellence, and ensure compliance within a dynamic environment.

You will lead regulatory submissions and interact with senior leadership to inform product development and market access, significantly impacting patient access to innovative therapies.