Senior Manager, Post Market Compliance

Requisition ID: 31747

At Terumo Blood and Cell Technologies, our 7,000 global associates proud to come to work each day, knowing that what we do impacts the lives of patients around the world.

We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells. With our innovative technologies and service offerings, we touch a patient's life every second of every day and are committed to continuing to increase the number of patients we serve.

With some of the best and brightest minds in the industry, an unmatched global footprint, comprehensive benefits and a distinct culture, Terumo Blood and Cell Technologies is a great place to work, grow and be part of a team that is focused on making a difference. Consider joining our team and unlock your potential.

The Post Market Compliance Senior Manager will oversee all aspects of the Post Market processes, including Complaint Handling / AER, Field Actions, and Periodic Reporting. This involves leading a global team ensuring compliant Global processes by staying abreast of regulatory expectations and industry best practices, facilitating a Global Center of Excellence with extended stakeholders, and owning the Global policies and tools. This team will also be executing to these Global processes and procedures and coordinating execution activities with the factories and regions. This person will work extensively with stakeholder departments such as Commercial, Operations, Service, Clinical, Medical Affairs and Regulatory on Post Market Surveillance strategy and execution.

As the global post market compliance leader and subject matter expert, the incumbent works closely with cross-functional quality and organizational leaders to drive continuous state of audit readiness. Provides inspirational guidance, bringing out the best in associates by instilling a bias for customer impact, data-driven results, commitment to excellence, and a collaborative, high-performing culture focused on continuous improvement and compliance. Develops and maintains exceptional internal and external relationships with stakeholders and regulatory agencies, regularly monitoring the external landscape as it relates to the Company's long-term business objectives. Ensures all quality activities are in accordance with applicable laws, rules and regulations of the intended markets meeting the highest quality standards and customer expectations.

DUTIES AND RESPONSIBILITIES

• Serve as subject matter expert in Post Market compliance (complaint handling / AER, field actions, post market surveillance reporting).
• Act as primary point of contact for audits / inspections (regulatory, customer, notified body) in these areas.
• Accountable to ensure that all the complaints (including high priority complaints) are processed in a timely manner that keeps the organization in good regulatory standing.
• Stay abreast of internal and external stakeholder requirements to efficiently deliver compliant processes which also deliver business and customer benefit.
• Lead a sizeable Global team working together on these shared QMS processes. Must be sensitive to cross-cultural considerations and flexible in working styles and times.
• Partner closely with Quality leaders in factories and regions on end-to-end process delivery.
• Partner closely with key stakeholders inside and outside of Quality (service, commercial, regulatory) to develop and maintain efficient and compliant processes to serve internal and external customers.
• Monitor the emerging intelligent automation landscape (AI, Robotic Process Automation, Augmented Reality among others) and deploy solutions that would drive productivity improvements.
• Serve on project teams to ensure Post Market considerations are considered.
• Ensures that the Quality Management System is established, implemented and maintained for effectiveness in accordance with applicable standards within scope of Quality Manual (including but not limited to ISO 13485, MDR, MDSAP, FDA Quality System Regulations).
• Develop, monitor, and report KPI's related to process efficiency and performance. Proactively detect emerging issues and drive continuous improvement.
• Manage personnel and all associated activities of the Post Market Compliance group including managing performance and developing talent.
• Assess and define department training needs. Confirm all training needs are met, and training is completed within the expected timeframesteam responsible for complaint intake, investigation, risk assessment, AER / MDR reporting, customer communication
• Ensure complaints are processed in timely and accurate manner and all reporting requirements are met.
• Lead team responsible for the Field Action determination and execution process.
• Ensure that Field Action escalations are properly managed and tracked.
• Interact with regulatory agencies and global points of contact for Field Action communications and updates.
• Lead team responsible for Post Market Surveillance plans and reports.
• Ensure flow of requisite information and summaries from multiple data sources according to predefined schedule.

MINIMUM QUALIFICATION REQUIREMENTS

Education

• Bachelor's degree or, equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
• Master's degree in engineering or related discipline is preferred.

Experience

• Minimum 10 years' experience in Quality /Quality Control function, with at least 5 years direct experience in the Post Market Surveillance field.
• Preferred minimum of 10 years Regulatory Compliance/Regulatory Affairs experience involving US FDA Class II or Class III medical devices.
• At least 5 years managerial experience, and prior leadership of large (40 ) and globally dispersed teams a plus.
• Experience in interfacing with global regulatory agencies (USFDA and or Notified Body inspections, audits or other similar regulatory body inspections).
• Comprehensive knowledge of U.S., European and other international regulations, standards and guidance applicable to medical devices, particularly in the Post-Market area (e.g. ISO 13485, 21 CFR 803, 21 CFR 806, 21 CFR 820, EU MDR, etc.).
• Experience in interfacing with FDA and/or other regulatory agencies, including preparing for and managing on-site external audits, responding to non-conformities and compiling formal responses (such as FDA 483s and warning letters).

Skills

• Must have strong theoretical knowledge of the Quality Management System functions in all primary disciplines, including in-depth practical knowledge of how to apply these principles.
• Extensive knowledge of U.S. and international medical device regulations and standards.
• Proven ability to solve practical problems in a collaborative manner which yields effective compliance with QMS and external standards while allowing for the use of efficient and flexible implementation approaches.
• Proven ability to interact with senior management team, including influencing other members in matters of significance to the organization.
• Demonstrated ability to organize and motivate cross-functional and multi-facility teams to meet quality goals.
• Excellent written and oral communication skills and a proven ability to communicate effectively. Proven ability to read and interpret documents of significant complexity, including external standards, design inputs, verification/validation protocols, and clinical studies.
• Must be able to generate, interpret and apply data analysis as a tool to drive improvement within the team and the larger organization.

• External and internal audit extensive experience especially interacting with Regulatory Bodies and the Food and Drug Administration (FDA).
• Drive to understand and meet customer expectations as relates to processes in scope.
• Strong Continuous Improvement background and commitment to process and compliance excellence.

Certificates, Licenses, Registrations:

• Certification (e.g. CQE, CQA, CRE, etc.) by a recognized certifying body (e.g. ASQ) is strongly desired.
• Six Sigma Black Belt or Lean certification desirable.

ADDITIONAL REQUIREMENTS

• There will be occasional requirement to work outside of normal business hours, consistent with other positions at this level.
• Some US and international travel will be required (< 25%).

PHYSICAL REQUIREMENTS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

In the typical office environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds.

Target Pay Range:$146,600.00to$183,300.00 -Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data
Target Bonus on Base:20.0%

At Terumo Blood and Cell Technologies, we provide competitive total reward offerings that consist of compensation, benefits, recognition, along with a wealth of other well-being, work-life and recognition programs which support in unlocking the potential for you and your family.Included in our expansive list of benefits offerings are multiple group medical, dental and vision plans, a robust wellness program, life insurance and disability coverages, also a variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance and much more.To help you save for retirement, we offer a 401(k) plan with a matching contribution and for work-life balance we have vacation and sick time programs for associates.For us, it's about protecting the personal welfare of our associates and their families, helping to achieve personal goals and offering those extra touches for convenience, security and overall peace of mind.

• Terumo Blood and Cell Technologies is part of Terumo Group, founded in 1921 and headquartered in Tokyo, Japan.
• In 2019, Terumo Blood and Cell Technologies reached $1 billion in revenue.
• We employ nearly 7,000 associates globally, with global headquarters in Lakewood, CO, U.S., and regional headquarters in Brussels, Buenos Aires, Singapore and Tokyo.
• We manufacture devices, disposable sets and solutions at our facilities in Belgium, India, Japan, Northern Ireland, the U.S. and Vietnam. Our global presence enables us to serve customers in more than 130 countries.
• Our core values help set our direction, guide our actions and keep us true to our corporate mission of contributing to society through healthcare.
  • Respect - Appreciative of others
  • Integrity - Guided by our mission
  • Care - Empathetic to patients
  • Quality - Committed to excellence
  • Creativity - Striving for innovation
• We contribute to the Leukemia and Lymphoma Society (LLS), raising $1.3 million USD since 2007.

We are proud to be an Equal Opportunity Affirmative Action Employer. All applicants will be afforded equal opportunity without discrimination because of race, color, religion, sex, gender identity or expression, sexual orientation, marital status, order of protection status, national origin or ancestry, citizenship status, age, physical or mental disability unrelated to ability, military status or an unfavorable discharge from military service.

Terumo Blood and Cell Technologies is committed to providing a safe, healthy and secure working environment.Our Colorado campus locations are tobacco-free workplaces, and we maintain a drug-free workplace and perform pre-employment substance abuse testing and detailed background verification.