1+ months

Senior Product Development (PD) Compliance Program Manager

Santa Ana, CA 92702
Senior Product Development (PD) Compliance Program Manager


Santa Rosa, California, United States

Requisition #:


Post Date:

May 17, 2022

**Senior Product Development (PD) Compliance Program Manager**

Careers That Change Lives

We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.

The Cardiac and Vascular Group brings all of our cardiac and vascular businesses together into one cross-functional, collaborative operating unit to employ the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe

The Senior PD Compliance Program Manager position has the primary responsibility to oversee and manage the PDP (product development process) and compliance-related initiatives within the Coronary (CRDN), Structural Heart and Aortic (SHA), Cardiac Surgery (CS), and Peripheral Vascular Health (PVH).

Reporting to the Director of PMO, this position will be part of leading the DECO (Design Control Compliance Office) group within the PMO (Project Management Office). This position will work with cross functional project teams and PMO representatives as a process expert, trainer, and coach for the PDP and design control-related activities as well as support continuous improvement initiatives within the business to drive better execution and compliance of the PDP process. This role will also be responsible for representing the Product Development and Design Control processes in internal and external audits and inspections.

**A Day in the Life**

+ Lead and maintain governance of a cross-OU product develop and design control team to ensure compliance to internal and external standards.

+ Develops, lead, implements, administers product development and design control compliance policies, procedures, and practices.

+ Leads or leverages cross business teams to evaluate, develop and manage projects for related to product development and/or design control compliance.

+ Act as a key subject matter expert and critical point of contact on the phase gate project realization and design control process to the product development organization and within broader Medtronic forums and initiatives.

+ Ensures alignment with legal and ethical standards of the organization.

+ Communicates with stakeholders, obtains stakeholder engagement to ensure the end products or processes will solve the business problems.

+ Provides product development, design control and compliance advice, investigates compliance problems, questions, or complaints and verifies deficiencies are corrected.

+ Develops and delivers employee communication and training and coaching programs that focus on the elements of a companywide product development and compliance program.

+ Analyzes trends and coordinates and/or prepares for internal and external audits of the functional compliance program.

+ Maintains current knowledge of design control regulations including 820.30 and ISO 13485, and industry guidance and interpretation that impact the companys compliance program.

**Must Have: Minimum Requirements**

+ Bachelors degree required

+ Minimum of 7 years of relevant experience with 5+ years of managerial experience, or advanced degree with a minimum of 5 years of relevant experience with 5+ years of managerial experience

**Nice to Have**

+ Experience working with Design Control regulation including 820.30 and ISO 13485.

+ Medical devise audit experience.

**About Medtronic**

We are a learning culture. An inventive and collaborative group. We are dedicated to making sure that every patient gets the best product when they need it. We have strong ties to our local

communities. Our vibrant employee communities respect and value individual experience and perspective as we aim to improve lives and the access to healthcare.

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Lets work together to address universal healthcare needs and improve patients lives. Help us shape the future.

Physical Job Requirements

The physical demands described within the Responsibilities section of this job description 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. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.


Posted: 2022-05-19 Expires: 2022-07-25

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Senior Product Development (PD) Compliance Program Manager

Santa Ana, CA 92702

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