Senior Compliance Specialist

Careers That Change Lives

Our Global Quality Strategy is rooted in the Medtronic Mission and our Quality Policy. Being a 'trusted partner' means always putting patient safety first, upholding product quality, and maintaining the highest ethical standards in our business relationships and programs.

A Day in the Life

The Senior Compliance Specialist Review, evaluate, and reconcile completion of activities related to Product Hold Orders (PHO). Answer questions and perform follow up with Operating Units and Global Device Quality teams to finalize activities and ensure all quality documents meet good documentation practices. Compile documents to track progress and close the record in coordination with the operating unit.

Responsibilities may include the following and other duties may be assigned.

• Will be responsible for end-to-end PHO process and have a strong impact on this process
• This role will be part of the Enterprise PHO team that is responsible for end-to-end PHO process
• Share compliance expertise, influence and strategize PHO decisions to enable timely initiation and closure of PHO, and consequently enabling us to serve our patients with products
• Ensuring compliance to PHO process and its requirements, driving timely resolution and closure

Must Haves

• Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A)
• Minimum of 3 years of relevant experience, or advanced degree with 0 years of experience.

Your Profile:

• Experience developing effective written communications and executive presentations.
• Project management experience with ability to manage multiple projects simultaneously.
• Experience in customer service, supply chain, or contracts
• Experience with FDA regulatory medical device requirements, 21CFR Part 806, Part 7; ISO 13485, Medical Device Directive.
• Excellent written and verbal communication abilities.
• Experience with Good Documentation Practices

About Medtronic

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. Let’s 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.