Senior Audit & Compliance Program Manager - CRM
MedtronicAbout the role
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
A Day in the Life
Bring your talents to an industry leader in medical technology and healthcare solutions – we’re a market leader and growing every day. Our expanding portfolio delivers measurable clinical and economic value – and opens doors. You will be empowered to shape your own career. We support your growth with the training, mentorship, and guidance you need to own your future success. Together, we can transform healthcare.At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the
extraordinary.
The Senior Audit & Compliance Program Manager is responsible for the Information Security Management System for the CRM Carelink network and will interface with key leaders and personnel in the PCS organization in CRM. This unique role is responsible for compliance and certification to ISO27001 as well as other related regulations and standards. This position will be based in Mounds View, MN and will report into the CRM Quality Systems and Compliance team.
A Day in the Life:
Responsibilities may include the following and other duties may be assigned.
Coordinates and/or completes internal/external risk assessments and/or audits and compliance in accordance with regulatory standards, which may include US and/or international regulatory agencies / authorities.
Plans and manages external audits for ISO27001 and HDH certifications.
Manages and oversees internal audit activities, which may include conducting and/or overseeing audits, investigations, and/or interviews; and preparing corresponding reports and documents; will also include planning and coordinating with an external auditing vendor.
Interprets and implements applicable regulations and standards as they apply to products, processes, practices and procedures for the ISMS.
May counsel stakeholders about these requirements as necessary.
Ensures compliance with internal and external regulatory agencies, which may include investigating and resolving compliance violations, questions, or concerns.
Analyzes audit data and presents findings to management and/or regulatory bodies in support of Corrective Action Plans, which may include coaching business partners on compliance gaps, data, and/or resulting corrective actions.
Develops and implements programs, communications, and/or training designed to increase employee awareness and knowledge of compliance policies and/or processes.
Conducts quarterly management reviews of the ISMS.
Travel up to 5% of the time
Must Have:
Bachelor's Degree
7+ years of relevant experience or 5+ years with an advanced degree
Direct experience with CAPA, audit and quality management review
Nice to Have:
Experience with Cardiac Rhythm Management products is highly valued
Experience in medical device, pharma, or combo products
Experience leading organizational change
Experience with data security and privacy
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
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.
Benefits & Compensation
Medtronic offers a competitive Salary and flexibl
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