Job Description

Senior Director, Regulatory Affairs

Strategic leader responsible for developing regulatory strategy for the Endoscopy business unit, delivering bestinclass visualization and connectivity products to market in the United States, Canada and Europe. Works closely with business unit leadership, Marketing, R&D, Clinical and Quality teams to advise on product positioning, entry and exit strategies.

Key Areas of Responsibility

• Ensure divisional achievement of quality, regulatory, and compliance targets.
• Direct activities to ensure new product development and product sustainment meet regulatory requirements.
• Develop, lead, and execute regulatory strategy aligned with business needs.
• Lead selection, supervision, development, and objectivesetting for team members.
• Establish best practices to ensure compliance and drive revenue through improved customer experience.
• Provide a platform for process improvement.
• Serve as alternate Management Representative when required.
• Define targets, KPIs, performance objectives for the team and manage direct reports to meet or exceed these targets.
• Recruit, select, and onboard top talent.
• Develop team talent to increase performance.
• Address performance issues proactively and maintain high team engagement.
• Lead advocacy activities of a more advanced and global strategic nature.

Education / Work Experience

• BS in Engineering or other relevant field of study.
• Minimum 10 years experience.
• Master's Degree or equivalent preferred.
• RAC desired.

Knowledge / Competencies

• Demonstrated knowledge of regulatory requirements, including ISO, FDA, and international requirements.
• Demonstrated expertise in regulatory systems in a regulated environment.
• Ability to manage complex projects.
• Strong verbal, written, and interpersonal communication skills.
• Teamwork and effective collaboration with crossfunctional management.
• Ability to manage a multidiscipline, multitechnology, teambased organization with responsibility for quality, regulatory, and compliance targets.
• Initiative and analytical decisionmaking.
• Experience with recruiting and people development.
• Influence across the organization.

Salary range: $171,500 - $379,000, plus bonus and shortterm and longterm financial incentives.

Benefits include medical, prescription drug, dental, vision, critical illness, accident, hospital indemnity, personalized healthcare support, wellbeing and tobacco cessation programs. Financial benefits include HSA, FSAs, 401(k), ESPP, life and disability insurance.

Applications are accepted for a minimum of 3 days.

Job Tags

Similar Jobs