Senior Regulatory Affairs Manager

Senior Regulatory Affairs Manager

The Senior Regulatory Affairs Manager leads global regulatory strategy for a portfolio of medical devices, overseeing regulatory pathways, submissions, risk assessment, and market-entry planning. This role serves as a strategic regulatory advisor throughout product development and lifecycle management, ensuring compliance with evolving global regulations and driving the implementation of regulatory requirements across the organization. The position also provides leadership and mentorship to regulatory affairs teams, partners closely with cross-functional stakeholders, and champions continuous improvement in regulatory processes and compliance initiatives.

Responsibilities:

• Lead global regulatory strategy for medical device portfolios, including defining regulatory pathways, planning submissions, assessing risks, and supporting market-entry initiatives.
• Oversee preparation, submission, and maintenance of regulatory filings and technical documentation with FDA, Notified Bodies, Health Canada, and other international regulatory authorities.
• Serve as a strategic regulatory advisor to guide product development and lifecycle management, ensuring regulatory requirements are integrated from concept through post-market activities.
• Monitor evolving global medical device regulations, standards, and guidance, and drive implementation of new regulatory requirements across the organization.
• Lead, mentor, and develop regulatory affairs teams, providing clear direction, coaching, and support to align with business objectives and portfolio priorities.
• Partner cross-functionally with R&D, Quality, Clinical, Marketing, Operations, and Commercial teams to address regulatory challenges and support product and portfolio decisions.
• Review product labeling, instructions for use, promotional materials, and product claims to ensure regulatory compliance and alignment with approved indications.
• Drive regulatory process improvements, including inspection readiness, audit support, and compliance initiatives, to enhance efficiency and robustness of regulatory systems.
• Communicate regulatory strategies, risks, timelines, and portfolio updates to Senior leadership and key stakeholders in a clear, concise, and actionable manner.
• Manage priorities across multiple projects and submissions, balancing resources and timelines to meet business and regulatory commitments.
• Support and influence decision-making by providing sound regulatory judgment, risk assessments, and recommendations in a fast-paced, regulated environment.
• Contribute to building and scaling the regulatory affairs function, including planning for team growth and developing capabilities to support future portfolio expansion.

Essential Skills:

• Minimum 8 years of directly relevant regulatory affairs experience in the medical device industry.
• Minimum 5 years of experience leading regulatory strategy for new product development and sustaining products.
• Minimum 4 years of direct people-management experience in regulatory affairs or a closely related function.
• Strong knowledge of FDA medical device regulations, including relevant pathways and submission types.
• Strong knowledge of EU Medical Device Regulation (EU MDR) and related European regulatory requirements.
• Strong knowledge of Health Canada medical device regulations and global regulatory frameworks.
• Proven ability to develop and execute regulatory strategies that support business objectives and mitigate regulatory risks.
• Demonstrated experience managing regulatory priorities across multiple projects and markets.
• Excellent verbal and written communication skills, with experience influencing both technical teams and executive leadership.
• Strong judgment and decision-making skills, with the ability to thrive in a fast-paced, highly regulated environment.
• Experience leading regulatory process improvement initiatives and supporting inspection readiness and audits.

Additional Skills & Qualifications:

• Regulatory Affairs Certification (RAC) or equivalent professional certification in regulatory affairs.
• Experience working with Notified Bodies and international regulatory authorities beyond FDA and Health Canada.
• Background in medical device product development and lifecycle management, including sustaining engineering and post-market activities.
• Experience reviewing labeling, promotional materials, and product claims for regulatory compliance.
• Track record of mentoring and developing regulatory professionals and building high-performing teams.
• Demonstrated ability to collaborate effectively with cross-functional partners, including R&D, Quality, Clinical, Marketing, Operations, and Commercial teams.
• Interest in driving continuous improvement in regulatory processes, systems, and documentation.
• Motivation to grow into broader leadership responsibilities and advance within an established organization.

Work Environment:

This role is primarily onsite, providing direct collaboration with cross-functional teams and close engagement with the regulatory affairs group. There may be flexibility to work from home on Fridays, depending on business needs. The Senior Regulatory Affairs Manager will initially manage a team of four regulatory professionals, with the opportunity to grow and expand the team over the next year. The environment is fast-paced and highly regulated, with a strong focus on quality, compliance, and cross-functional partnership. The organization offers an established structure with clear opportunities to lead regulatory strategy and advance into broader leadership responsibilities.

Job Type & Location:

This is a Contract to Hire position based out of Centennial, CO.

Pay and Benefits:

The pay range for this position is $72.00 - $91.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type:

This is a fully onsite position in Centennial, CO.

Application Deadline:

This position is anticipated to close on Oct 19, 2026.