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.
Ensure complete and accurate maintenance and reporting of Medical Device Reports (MDRs), Adverse Drug Experience (ADE) data or adverse reaction data as required by regulatory agencies
Review and analyze clinical databases for the extraction of ADE data and integrates the data to ensure the creation of a unified database consistent with the aims and purposes of ADE standardization and internalization as well as to ensure the accuracy and quality of safety summaries
Act as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements
Lead or leverage cross functional teams to evaluate, develop and manage projects for key business processes
Oversee and manage the operational aspects of ongoing projects and serves as liaison between project team and stakeholders
Assess project issues and supports project team in development of resolutions to meet goals and objectives.
Understand current and upcoming Medical Device Reporting (MDRs) and EU Vigilance Reporting requirements by regulatory bodies and ensure adequate implementation or regulations
Must Haves
Bachelor’s Degree with 7+ years of Quality and/or Regulatory experience OR advanced degree with 5+ years of Quality and/or Regulatory experience
Nice to Have
Demonstrated ability to collaborate and influence in a matrixed environment and to work effectively with in-house functional team
Excellent verbal, written and presentation communication skills
Proven ability to build and facilitate strong, productive working relationships with a wide variety of cross-functional and customer contacts
Program management experience in the medical device, aerospace, automotive or other highly regulated industry
Experience devising and implementing streamlined processes and strategic programs to improve efficiency, timeliness, and productivity
Experience in leading within matrix organizations requiring strong influence management skills
Change agent --willingness and ability to lead and institute change
Influence management skills; experience working collaboratively at all levels in matrix environment to build and maintain the positive relationships required to accomplish organizational goals
Excellent communication skills and interpersonal/team effectiveness with ability to succinctly and accurately communicate to various levels of management and employees
Business acumen; ability to think and act from an overall “best for the business” perspective
Results oriented; strong sense of urgency
Strong analytical, planning, organization and time management skills to effectively develop and execute comprehensive programs and budgets
Effective decision-making skills with ability to negotiate and balance decisions and priorities across needs of several functional departments and willingness to make tough decisions
Makes timely decisions in the face of risk and uncertainty
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.
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 insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple 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 match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital 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
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 90,000+ 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 law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.