Global Regulatory Affairs Leader - Medical Devices

Actalent; Centennial (CO); Hybrid; USD 99,000 - 125,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Plan

Life Insurance

Disability Insurance

HSA

Transportation benefits

PTO/Time Off

Job summary

Actalent is seeking a Senior Regulatory Affairs Manager to lead global regulatory strategy for medical device portfolios. You will guide submissions, risk assessments, and market-entry planning, and mentor regulatory teams to ensure compliance across regions.

The role requires strong knowledge of FDA regulations, EU MDR, Health Canada, and cross-functional collaboration with R&D, Quality, and Marketing. Onsite with potential Fridays remote, contract-to-hire based in Centennial, CO.

Qualifications

• Minimum 8 years in regulatory affairs for medical devices.
• Minimum 5 years leading regulatory strategy in product development.
• Minimum 4 years of people-management experience.
• Strong knowledge of FDA medical device regulations.
• Strong knowledge of EU MDR and Health Canada regulations.
• Ability to develop and execute regulatory strategies.
• Experience engaging with Notified Bodies and international authorities.

Responsibilities

• Lead global regulatory strategy for medical device portfolios, including defining regulatory pathways and planning submissions.
• Oversee preparation, submission, and maintenance of regulatory filings and technical documentation with FDA and international authorities.
• Guide product development and lifecycle management with regulatory requirements.
• Monitor evolving global regulations and drive implementation across the organization.
• Lead, mentor, and develop regulatory affairs teams.
• Collaborate with R&D, Quality, Clinical, Marketing, Operations, and Commercial teams.

Skills

Regulatory strategy

Global submissions

Leadership

Cross-functional collaboration

FDA regulations

Team mentoring

Regulatory risk assessment

Communication

Education

RAC certification

Job description

Actalent is seeking a Senior Regulatory Affairs Manager to lead global regulatory strategy for medical device portfolios. You will guide submissions, risk assessments, and market-entry planning, and mentor regulatory teams to ensure compliance across regions.

The role requires strong knowledge of FDA regulations, EU MDR, Health Canada, and cross-functional collaboration with R&D, Quality, and Marketing. Onsite with potential Fridays remote, contract-to-hire based in Centennial, CO.