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The Senior Director, Regulatory Affairs Global Strategy Implementation partners with MedTech Surgery business unit regulatory and regional leaders to set strategic direction and priorities for product registration, launch, and changes in regulations. They will partner with MedTech Surgery business unit regulatory for the development and maintenance of strategies during pre-market, launch, and post market phases of product life cycle.

Major Duties & Responsibilities

• Responsible for establishing and maintaining relationships with Notified Bodies for the business unit.

• Manages execution and handles international requests for registrations, renewals, and discontinuations.

• Provides business unit RA presence and support in the region for locally specific processes e.g. Economic Operator, etc.

• Establishes standard operational procedures to achieve efficiency within the regulatory affairs organization, including collaborating with other functions to drive the development of regulatory processes and controls to ensure product compliance in a timely manner

• Monitors complex issues for market access of products in strategic markets, and, when necessary, develop and lead remediation activities.

• Builds strong and positive relationship with Regulatory leaders across MedTech and cross-sector as well as with cross-functional leaders in Supply chain and Commercial to be recognized as a trusted voice of the MedTech Surgery business.

• Participates, as needed, in the integration of acquisitions (due diligence initiatives and compliance assessments) and coordination of work related to divestitures

• Leads, builds, and develops a team of Regulatory professionals across multiple locations to ensure strong talent pipeline and budget adherence.

• Responsible for presenting business-related issues or opportunities to next management level e.g. dashboards, metrics

Qualifications

• Bachelor's degree with a minimum of 10 years of global, large, healthcare products industry related experience OR an Advanced Degree with a minimum 7 years of related experience is required

• The ability to represent the function during senior, cross-functional, or leadership interactions

• Proven track record of leadership success and the ability to develop people

• Proven track record of strategic planning and ability to partner and influence cross-functional department partners

• Strong results orientation and organization

• Ability to communicate effectively with a diverse clientele base

• Experience working collaboratively internally and with external partners

• Up to 20% travel internationally and domestically

The anticipated base pay range for this position is $193,000 to $333,500. California Bay Area - The anticipated base pay range for this position is $238,000 to $382,950.