Senior Regulatory Compliance Specialist
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Job Location:
Kansas City, KS - USA
Yearly Salary:
$ 70600 - 141200
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Oracle Health is a comprehensive suite of healthcare technology solutions designed to help organizations advance patient care improve operational efficiency and enhance caregiver experiences. Building on Oracles global expertise in cloud technology data management and analytics Oracle Health delivers integrated electronic health records (EHR) population health tools and data-driven insights for hospitals clinics and health systems. By connecting data and workflows across the continuum of care Oracle Health empowers providers to make informed decisions streamline processes and drive better health outcomes.
The Senior Compliance Manager provides guidance to cross-functional teams on medical device quality system compliance with a focus on quality system support for CE marking processes and requirements under the EU Medical Device Regulation (EU MDR).
Responsibilities
The Senior Compliance Manager will provide quality system support through conformity assessment procedures technical documentation preparation medical device file development and maintenance risk management and post-market surveillance for medical device market access. The Senior Compliance Manager coordinates and assist with both internal and external audits including Notified Body audits related to CE marking and helps manage corrective and preventive actions (CAPA). They assist with monitor compliance with changing European regulatory requirements and act as a subject matter expert on EU market authorization.
The incumbent maintains up-to-date knowledge relevant regulations works collaboratively with cross-functional teams to meet quality objectives analyses HQMS data and metrics for management reporting and supports supplier quality management activities.
Key Skills and Requirements
- 5 plus years of relevant experience
- BA/BS or advanced degree preferred
- Have an understanding of quality management system standards and risk management.
- Excellent written and verbal communication skills.
- Project Management Skills
Ability to adjust and adapt to changing priorities in a dynamic environment.
Qualifications
Disclaimer:
Certain US customer or client-facing roles may be required to comply with applicable requirements such as immunization and occupational health mandates.
Range and benefit information provided in this posting are specific to the stated locations only
US: Hiring Range in USD from: $70600 to $141200 per annum. May be eligible for bonus and equity.
Oracle maintains broad salary ranges for its roles in order to account for variations in knowledge skills experience market conditions and locations as well as reflect Oracles differing products industries and lines of business.
Candidates are typically placed into the range based on the preceding factors as well as internal peer equity.
Oracle US offers a comprehensive benefits package which includes the following:
1. Medical dental and vision insurance including expert medical opinion
2. Short term disability and long term disability
3. Life insurance and AD&D
4. Supplemental life insurance (Employee/Spouse/Child)
5. Health care and dependent care Flexible Spending Accounts
6. Pre-tax commuter and parking benefits
7. 401(k) Savings and Investment Plan with company match
8. Paid time off: Flexible Vacation is provided to all eligible employees assigned to a salaried (non-overtime eligible) position. Accrued Vacation is provided to all other employees eligible for vacation benefits. For employees working at least 35 hours per week the vacation accrual rate is 13 days annually for the first three years of employment and 18 days annually for subsequent years of employment. Vacation accrual is prorated for employees working between 20 and 34 hours per week. Employees working fewer than 20 hours per week are not eligible for vacation.
9. 11 paid holidays
10. Paid sick leave: 72 hours of paid sick leave upon date of hire. Refreshes each calendar year. Unused balance will carry over each year up to a maximum cap of 112 hours.
11. Paid parental leave
12. Adoption assistance
13. Employee Stock Purchase Plan
14. Financial planning and group legal
15. Voluntary benefits including auto homeowner and pet insurance
The role will generally accept applications for at least three calendar days from the posting date or as long as the job remains posted.
Career Level - IC3
Required Experience:
Senior IC
Key Skills
- Athletics
- Corporate Banking
- Dreamweaver
- Facilities
- IT Support
About Company
As a world leader in cloud solutions, Oracle uses tomorrow’s technology to tackle today’s challenges. We’ve partnered with industry-leaders in almost every sector—and continue to thrive after 40+ years of change by operating with integrity. We know that true innovation starts when eve ... View more
