Post Market Surveillance Regulatory Manager (Medical Devices)
About The Position
The Post Market Surveillance Regulatory Manager is a key contributor to the success of the Owens & Minor QARA organization. The Manager is responsible for establishing an efficient and effective global program to audit quality systems and compliance areas such as FCPA and an effective and compliant Post Market Surveillance (PMS) program. This is a global role that supports all Owens & Minor and ensures the Global QARAC Audit and PMS Program is compliant with applicable standards and regulations and is devoid of complexity that reduces effectiveness and/or efficiency whilst empowering teammates to improve outcomes. This role is remote and accepts applications within the United States.
Requirements
- Must have experience with FDA reporting and compliance specifically with medical devices.
- Experience managing a team
- Minimum 4-5 yrs experience
- Bachelors Degree
- Medical devices experience (required)
Responsibilities
- Manages and maintains an Owens & Minor Global QARAC Audit program that harmonizes QARA and Compliance internal audit processes across Owens & Minor to meet customer and regulatory requirements; continuously monitored and improved; execute proficient auditors using appropriate audit protocols.
- Manages and maintains an Owens & Minor Global PMS program that harmonizes PMS processes across Owens & Minor to meet customer and regulatory requirements; meets all requirements in terms of eMDR and Vigilance reporting; is continuously monitored and improved.
- Supports the effective execution of the QARAC audit program by identifying and facilitating a team of qualified, independent internal QARAC auditors.
- Maintains a centralized log of all internal and third party audits, findings and status of responses.
- Accountable for the centralized maintenance of all documentation including subsequent follow up, tracking and closure of any findings that result from such audits.
- Facilitates the sharing of best practices / learnings and initiatives from the quality system audit program throughout Owens & Minor.
- Identifies and shares industry best practices.
- Conducts proactive data analysis and promotes a culture of continuous improvement to identify opportunities and improve the Owens & Minor global quality and compliance systems.
- Ensures monthly reports are available on key process metrics and are represented on the global dashboard.
Benefits
- Comprehensive Healthcare Plan - Medical, dental, and vision plans start on day one of employment for full-time teammates.
- Educational Assistance - We offer educational assistance to all eligible teammates enrolled in an approved, accredited collegiate program.
- Employer-Paid Life Insurance and Disability - We offer employer-paid life insurance and disability coverage.
- Voluntary Supplemental Programs – We offer additional options to secure your financial future including supplemental life, hospitalization, critical illness, and other insurance programs.
- Support for your Growing Family – Adoption assistance, fertility benefits (in medical plan) and parental leave are available for teammates planning for a family.
- Health Savings Account (HSA) and 401(k) - We offer these voluntary financial programs to help teammates prepare for their future, as well as other voluntary benefits.
- Paid Leave - In addition to sick days and short-term leave, we offer holidays, vacation days, personal days, and additional types of leave – including parental leave.
- Well-Being – Also included in our offering is a Teammate Assistance Program (TAP), Calm Health, Cancer Resources Services, and discount programs – all at no cost to you.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
