Program Manager for Global Compliance

Summary

The Program Manager for Global Product Compliance (CCN - Compliance Change Notification) is responsible for driving the program execution on the global Anesthesia and Vaporizer products to guarantee the portfolio products are compliant with the up-to-date Regulatory and Standard requirements (Such as RoHS, REACH, PFAS, Regions registration requirement change, General safety and performance standard updates, Anesthesia particular standard updates, EMC standard update, Usability standard update, Cybersecurity standard update, etc.). The Global Compliance Leader develops project plans and ensures the necessary resources are executing to the plans, resulting in plan success. The Global Compliance Leader leads cross-functional teams to deliver program content resulting in products that meet all quality, content, schedule, and budget targets.

A successful candidate will create an inclusive, positive, and empowering team environment, and foster a culture of compliance and continuous improvement while leading global and cross-functional teams. A successful candidate will also balance multiple projects simultaneously and drive clear decisions based on business objectives. The Global Compliance Leader is accountable for ensuring global Anesthesia and Vaporizer products compliance with the latest regulatory and standard requirements, through the following activities:

• CCN Process Establishment: Establishing the process and Operating Mechanism to manage the CCNs to optimize the global engineering resource and ensure the products compliance to the standard and regulatory changes.

• CCN Interpretation: Working with Global CCN SME, Safety and Regulatory Engineer (SRE), Product Regulatory Affair (PRA), Quality Assurance (QA) and the relevant Technical Expert to review the CCNs from the countries all over the world to understand the CCN content and change details.

• CCN Evaluation for Global Products: Leading the CCN review with the global program teams to evaluate the impact to the different segment Anesthesia and Vaporizer products (Premium products in Madison USA, Performance products in Wuxi China, Value products in Bangalore India).

• Project Planning and Execution: Developing the project plans for each affected CCN and driving the execution with the help from different segment Program Managers according to the committed timelines and within the CCN compliance due date.

• Project Reporting and Escalation: Monitoring the project execution and regularly reporting to the key stakeholders, identifying the risks during the project execution and involving leadership team to prioritize the resource and budget when the forward production or New Product Introduction (NPI) is heavily impacted.

• Bachelors or masters degree within appropriate Engineering/Science discipline.

• Excellent verbal and written communication skills in English, ability to communicate across organization levels and to connect with different audiences in a multicultural environment.

• A candidate with Program Management experience or Regulatory & Standard work related is preferred. At least with the proven track record of driving projects forward and delivering results without supervision.

• A decision maker, strong communication, collaboration and leadership skills to work effectively with global cross-functional teams.

• A clear thinker who can analyze data to establish a direction to proceed in a timely and logical manner.

• Strong commitment to compliance with relevant regulations and procedures, and the demonstrated knowledge or experience in Medical Device development under Quality Management System.

GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership always with unyielding integrity.

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything youd expect from an organization with global strength and scale, and youll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

Relocation Assistance Provided: No

Locations - Location:
Wuxi, Jiangsu, China, 214028