Compliance Program Manager
Compliance Program Manager
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$ 111200 - 166800
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
Act boldly. Compete to win. Move with speed and decisiveness. Foster belonging. Deliver resultsthe right way. Thats the Medtronic Mindset our cultural norms. Our brand is rooted in action not just words. The Medtronic Mindset defines the expectations of our culture. Every person here plays a role in bringing it to life. We recognize your extraordinary potential to ensure future generations live better healthier lives.
The Compliance Program Manager plays a critical role in ensuring the effective execution of Field Corrective Actions (FCA) across the role is responsible for overseeing the enterprise FCA planning process ensuring compliance with quality system requirements and driving continuous improvement in the FCA process. Additionally the Compliance Program Manager will help to foster a culture of accountability and excellence while managing the end-to-end FCA process. This position demands a proactive approach to problem-solving exceptional organizational skills and a strong commitment to maintaining the highest standards of regulatory compliance and patient safety.
Responsibilities may include the following and other duties may be assigned.
Prioritize patient safety and regulatory compliance by acting swiftly in collaboration with cross functional partners to ensure timely FCA planning and approval.
Partner with Operating Unit (OU) and region to drive alignment on FCA strategy and execute per plan by following released procedure steps
Follow the process per procedures align with OUs as needed to ensure the standard process is followed and executed
Support internal & external audits as needed to represent the process and team
Support continuous improvement projects to increase effectiveness efficiency and compliance
Ensure alignment with legal and ethical standards of the organization
Develop implement administer and certify compliance policies procedures and practices.
Manage internal team responsibilities as assigned
Draft revise and finalize FCA and regulatory documentation as needed for customers and FDA.
Onsite
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.
Must Have: Minimum Requirements
To be considered for this role please ensure the minimum requirements are evident in your applicant profile.
Bachelors Degree in Engineering Science or technical field with 5 years of work experience in Engineering Quality and/or experience in a regulated industry OR Advanced Degree in Engineering Science or technical field with 3 years of work experience in Engineering Quality and/or experience in a regulated industry.
Nice to Have
Capable of effectively managing multiple demands from a variety of sources.
Strong expertise with managing complex situations comfortable escalating issues and operating in grey area.
Excellent written and verbal communication abilities.
Experience with FDA regulatory medical device requirements 21CFR Part 806 Part 7; ISO 13485 Medical Device Directive.
Experience supporting internal and external audits
Experience supporting continuous improvement projects
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
