Senior Audit & Compliance Program Manager - CRM
Senior Audit & Compliance Program Manager - CRM
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$ 140000 - 210000
1 Vacancy
Job Description
At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll 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 were 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 -person exchanges are invaluable to our work. Were 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:
Bachelors 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 flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits resources and competitive compensation plans designed to support you at every career and life stage.
The following benefits and additional compensation are available to those regular employees who work 20 hours per week: Health Dental and vision insuranceHealth Savings AccountHealthcare Flexible Spending AccountLife insurance Long-term disability leaveDependent daycare spending accountTuition assistance/reimbursement andSimple Steps (global well-being program).
The following benefits and additional compensation are available to all regular employees:Incentive plans 401(k) plan plus employer contribution and matchShort-term disabilityPaid time offPaid holidaysEmployee Stock Purchase PlanEmployee Assistance ProgramNon-qualified Retirement Plan Supplement (subject to IRS earning minimums) andCapital Accumulation Plan (available to Vice Presidents and above or subject to IRS earning minimums).
Regular employees are those who are not temporary such as interns. Temporary employees are eligible for paid sick time as required under applicable state law and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.
Further details are available at the link below:
Medtronic benefits and compensation plans
About Medtronic
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission to alleviate pain restore health and extend life unites a global team of 95000 passionate people.
We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the R&D lab to the factory floor to the conference room every one of us experiments creates builds improves and solves. We have the talent diverse perspectives and guts to engineer the extraordinary.
Learn more about our business mission and our commitment to diversity here.
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 addition Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
If you are applying to perform work for Medtronic Inc. (Medtronic) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County you can findhere a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
Required Experience:
Manager
Employment Type
Full-Time
