Senior Manager, Regulatory Affairs Aesthetics Medical Device (WA)

Role Summary

Senior Manager, Regulatory Affairs Aesthetics Medical Device (WA) – Lead global regulatory strategy and ensure timely registrations and compliance for Solta Medical Inc. products, collaborating with Quality, R&D, Operations, and regional RA peers.

Responsibilities

• Develop and implement global regulatory strategy and roadmaps for assigned product portfolio.
• Lead regulatory resources to ensure timely product registrations, planning for new product introductions and changes, and maintain regulatory compliance.
• Provide regulatory plans, risk assessment guidance, and corrective actions; guide global regulatory strategy including US FDA clearance, Health Canada, CE Marking, global registrations, and clinical evaluations.
• Address complex issues requiring deep company knowledge; participate in development of methods, techniques, and evaluation criteria for projects and people.
• Ensure budgets and schedules meet corporate requirements.
• Conduct research and communication of new/revised regulatory requirements; perform impact assessments and support implementation of changes.
• Develop and maintain positive relationships with regulatory agencies through submissions planning and follow-up.

Qualifications

• 10+ years of experience in the medical device industry; 5+ years in Electrical/Active medical devices; 5+ years of global regulatory knowledge; 2+ years of people management.
• Experience authoring complete 510(k) submissions, Health Canada licenses (Class II+), EU MDR technical files (Class II+).
• Experience in participating in national/international standards activities.
• Undergraduate degree required, preferably in a science-related field.
• Strong understanding of Change Management / Lifecycle; management of medical device products and regulatory impact in US, Canada, and EU.
• Self-directed, problem-solving mindset; ability to work effectively in cross-functional teams in a fast-paced environment.
• RAC preferred but not required.
• Excellent written and communication skills.

Skills

• Regulatory strategy development
• Global regulatory submissions
• Cross-functional collaboration
• Regulatory intelligence and change management
• Communication with regulatory agencies

Education

• Undergraduate degree in science or related field.

Additional Requirements

• No explicit travel requirements; not specified as essential.