Regulatory Strategy Leader, Medical Devices

Actalent; Centennial (CO); Sur place; USD 99 000 - 125 000; Plein temps

Résumé du poste

Actalent seeks a Senior Regulatory Affairs Manager to lead global regulatory strategy for medical device portfolios, including regulatory pathways, submissions, and lifecycle management.

You will mentor regulatory teams, collaborate with R&D, Quality, Clinical, and Marketing, and drive continuous improvement in regulatory processes, ensuring compliance across markets and product lifecycles.

Qualifications

• 8+ years in regulatory affairs for medical devices.
• 5+ years leading regulatory strategy for new and sustaining products.
• 4+ years direct people management in regulatory affairs.
• Strong knowledge of FDA medical device regulations and pathways.
• Strong knowledge of EU MDR and European regulatory requirements.
• Strong knowledge of Health Canada regulations and global frameworks.
• Proven ability to develop and execute regulatory strategies aligned with business goals.
• Experience managing priorities across multiple projects and markets.
• Excellent verbal and written communication, able to influence executives.
• Strong judgment and decision-making in a fast-paced, regulated environment.
• Experience leading regulatory process improvements and audits.

Responsabilités

• Lead global regulatory strategy for medical device portfolios, defining pathways, planning submissions, assessing risks and market-entry initiatives.
• Oversee preparation, submission, and maintenance of regulatory filings and technical documentation with FDA, Notified Bodies, Health Canada, and other international authorities.
• Guide product development and lifecycle management by embedding regulatory requirements from concept through post-market.
• Monitor evolving regulations and drive implementation of new requirements across the organization.
• Lead, mentor, and develop regulatory affairs teams to align with business objectives.
• Partner with R&D, Quality, Clinical, Marketing, Operations, and Commercial teams to address regulatory challenges.
• Review labeling, IFU, promotional materials, and claims for compliance with approvals.
• Drive process improvements, inspection readiness, audits, and robust regulatory systems.
• Communicate strategies, risks, timelines, and portfolio updates to senior leadership clearly.
• Manage priorities across multiple projects and submissions, balancing resources and timelines.
• Provide regulatory judgment and risk assessments to influence decisions in a fast-paced environment.
• Contribute to building and scaling the regulatory function with future portfolio expansion.

Connaissances

Regulatory experience

Regulatory leadership

People management

FDA regulations

EU MDR

Health Canada

Regulatory strategy

Cross-functional

Communication skills

Process improvement

Formation

Regulatory Affairs Certification (RAC)

Experience with Notified Bodies

Description du poste

Actalent seeks a Senior Regulatory Affairs Manager to lead global regulatory strategy for medical device portfolios, including regulatory pathways, submissions, and lifecycle management.

You will mentor regulatory teams, collaborate with R&D, Quality, Clinical, and Marketing, and drive continuous improvement in regulatory processes, ensuring compliance across markets and product lifecycles.