Global Technical Manager – Sterilization

About the Role

The role is complex and multifaceted, requiring a deep understanding of sterilization processes, regulatory frameworks, and quality management systems. The successful candidate will be responsible for acting as a line manager and leading a team of MDR Product Assessors-Sterilization, providing technical advice, and establishing competence criteria for product assessors and auditors.

What You Will Do

• Oversee sterilization processes within medical devices and provide technical support across all certification schemes, including MDR, MDD, UK MDR, ISO13485, MDSAP, and IVDR
• Act as a line manager and lead the team of MDR Product Assessors-Sterilization
• Provide technical advice in relation to sterilization to support all stages of the medical device conformity assessment process
• Establish competence criteria, update, deliver, and maintain appropriate training packages for Product Assessors (sterilization team) and sterilization auditors
• Develop, maintain, and implement sterilization QMS documentation related to medical devices conformity assessment process
• Manage the development and implementation, including approval process for Product Assessors (sterilization team) and sterilization auditors, new personnel, and for on-going monitoring and re-approval of personnel
• Drive team performance against global targets, with full accountability for chargeability, utilization, productivity, timeliness, assessment quality, and regulatory compliance
• Lead proactive decision-making, ensuring operational and technical issues are resolved at the appropriate level with minimal escalations and delays
• Act as a primary technical reference point within the area of responsibility, providing clear and consistent guidance to the team, Delivering Offices (DOs), and Hubs
• Establish a culture of accountability and performance by setting clear expectations, defining individual and team goals, and monitoring delivery against operational and technical objectives

What We Are Looking For

• A minimum of 5 years of experience in a similar role, preferably in the medical device industry
• Strong knowledge of sterilization processes, regulatory frameworks, and quality management systems
• Experience in leading a team and providing technical guidance and support
• Excellent communication and interpersonal skills
• Ability to work in a fast-paced environment and prioritize multiple tasks
• Strong problem-solving and analytical skills
• Experience with certification schemes, including MDR, MDD, UK MDR, ISO13485, MDSAP, and IVDR
• Knowledge of regulatory requirements, including EU MDR and IVDR

Nice to Have

• Experience in a notified body or similar organization
• Knowledge of medical device regulation and conformity assessment processes
• Experience in developing and implementing training packages
• Certification in a relevant field, such as Quality Management or Regulatory Affairs

Benefits and Perks

• Competitive salary and benefits package
• Opportunity to work with a leading company in the medical device industry
• Flexible working hours and remote work options
• Professional development opportunities, including training and certification programs
• Access to a global network of professionals in the medical device industry
• Comprehensive health and wellness program
• Generous paid time off and holiday package

• Tip: Ensure you have a strong understanding of sterilization processes and regulatory frameworks, including MDR, MDD, UK MDR, ISO13485, MDSAP, and IVDR.
• Be prepared to provide specific examples of your experience in leading a team and providing technical guidance and support.
• Make sure you have a clear understanding of the company's commitment to integrity and compliance, and be prepared to provide examples of how you have demonstrated these values in your previous roles.
• Highlight your ability to work in a fast-paced environment and prioritize multiple tasks, and be prepared to provide examples of how you have managed competing demands in previous roles.
• Consider obtaining certification in a relevant field, such as Quality Management or Regulatory Affairs, to demonstrate your expertise and commitment to the industry.
• Research the company's culture and values, and be prepared to discuss how you align with these and how you can contribute to the organization's success.