Director, Regulatory Operations

The Director, Regulatory Operations leads regulatory compliance for the Endoscopy Division and provides strategic leadership to cross-functional teams, driving compliance initiatives and ensuring timely market access for products in alignment with applicable regulations. The Director will be responsible for roughly 5 direct reports and a total team of approximately 40-50 team members, and is required to be based in Flower Mound, TX with a hybrid work schedule of three days per week in the office. Relocation support can be provided.

• Leads organization engaged in regulatory compliance such as Complaint Handling, Reporting and Field Actions and directs interaction with regulatory agencies on such matters.
• Accountable for maintaining, monitoring, and reporting post market surveillance performance to ensure regulatory requirements are met with external regulatory bodies/agencies.
• Provide leadership to regulatory team to ensure achievement of business goals and objectives by ensuring access to market of products compliant with all applicable local, state and federal agencies and regulatory bodies.
• Accountable for ensuring cross functional alignment and support to meet regulatory compliance requirements.
• Direct and contribute to initiatives within the organization, with groups engaged in the development of good regulatory practice and policy.
  
  

Responsibilities:

• Lead the Regulatory Compliance organization including people management and ensuring global regulatory compliance within associated division or business units
• May serve as Person Responsible for Regulatory Compliance (PRRC) under the EU Medical Device Regulation
• May take responsibility for handling regulatory agency audits and communication with regulatory agencies.
• Accountable for effective product field action execution including customer interactions and reporting to regulatory agencies.
• Influence initiatives, decisions and processes for the organization.
• Implement regulatory system changes to support evolving regulations and international standards.
• Provide a strategic direction and tactical focus to the Regulatory Affairs organization and influence the direction of divisional RA activities.
• Establish standard process to ensure appropriate resolution and management of the responsible task owner.
• Chair meetings required to drive closure of regulatory issues.
• May serve as PRRC under EU MDR
• Manage and provide updates for regulatory metrics. Implement appropriate enhancements.
• Represent regulatory processes during internal and external audits.
• Define targets, KPIs, performance objectives, etc. for individuals within functional role, and manage direct reports to meet or exceed these targets.
• Recruit, select, and on-board top talent.
• Develop talent within team to increase performance. Actively address performance issues on team.
• Maintain a high level of team engagement.
• Participate in advocacy activities of a more advanced strategic nature.
  
  

Education/ Training:

• Bachelor’s degree required, life sciences, nursing or engineering (mechanical, electrical, industrial, software, biomedical, computer, biology, physics, chemistry, etc.) preferred
• Master's Degree or equivalent preferred
• Regulatory Affairs Certification desired
  
  

Skills/ Experience:

• Minimum of 10 years experience required
• 2 - 4 years of Management Experience
• Demonstrated knowledge and application of regulatory requirements, including ISO, FDA, and International requirements (i.e., Medical Device Regulation)
• Demonstrated expertise in regulatory systems in a regulated environment.
• Demonstrated project management skills.
• Demonstrated verbal, written, and interpersonal communication skills.
• Demonstrated ability to work in a team environment, interact effectively with management from other functions.
• Demonstrated ability to manage a multi-discipline, multi-technology, team-based organization and assume responsibility of quality, regulatory, and compliance targets.
• Demonstrated ability to initiate work.
• Demonstrated analytical ability.
• Demonstrated ability to make effective decisions.
• Experience with recruiting, people development.
• Influence across the organization.
  
  

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.