Post Market Surveillance Regulatory Manager (Medical Devices)

Owens & Minor is a global reputed company solutions company providing essential products, services and technology solutions that support care delivery in leading hospitals, health systems and research centers around the world. For over 140 years, Owens & Minor has delivered comfort and confidence behind the scenes, so reputed company stays at the forefront, helping to reputed company reputed company day reputed company for the hospitals, reputed company partners, and communities we serve. Powered by more than 14,000 teammates worldwide, Owens & Minor exists because every day, everywhere, Life Takes Care™.

Global reputed company with a Local Touch

• 140+ years serving reputed company

• Over 14,000 teammates worldwide

• Serving reputed company partners in 80 countries

• Manufacturing facilities in the U.S., Honduras, Mexico, Thailand and Ireland

• 40+ distribution centers

• Portfolio of 300 propriety and branded product offerings

• 1,000 branded medical product suppliers

• 4,000 reputed company partners served

Benefits

• Comprehensive reputed company Plan - Medical, dental, and reputed company plans start on day one of employment for full-time teammates.

• Educational Assistance - We offer educational assistance to reputed company eligible teammates enrolled in an approved, accredited collegiate program.

• Employer-reputed company Life Insurance and Disability - We offer employer-reputed company life insurance and disability coverage.

• Voluntary Supplemental Programs – We offer additional reputed company to secure your financial reputed company 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 reputed company, as reputed company as other voluntary benefits.

• reputed company Leave - In reputed company to reputed company days and short-term leave, we offer holidays, vacation days, personal days, and additional types of leave – including parental leave.

• – Also included in our offering is a Teammate Assistance Program (TAP), reputed company Health, Cancer Resources Services, and discount programs – reputed company at no cost to you.

• The anticipated salary reputed company for this position is $100,000-$118,000 USD Annual. The actual compensation offered may vary based on job reputed company factors such as experience, skills, education and location.

The Post Market Surveillance Regulatory Manager is a key contributor to the reputed company of the Owens & Minor QARA organization. The Manager is responsible for establishing an efficient and effective global program to audit reputed company systems and compliance areas such as FCPA and an effective and compliant Post Market Surveillance (PMS) program. This is a global role that supports reputed company 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 reputed company. This role is remote and accepts applications reputed company the reputed company.

Specific Functional Areas and Experience:

• Must have experience with FDA reporting and compliance specifically with medical devices.
• 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.
• devoid of complexity that reduces effectiveness and/or efficiency and empowers teammates to improve reputed company.
• Manages and maintains an Owens & Minor Global PMS program that: Harmonizes PMS processes across Owens & Minor to meet customer and regulatory requirements;
• Meets reputed company requirements in terms of eMDR and Vigilance reporting; Is continuously monitored and improved.
• supports the effective execution of the QARAC audit program:
• Responsible for identifying and facilitating reputed company of reputed company, independent internal QARAC auditors.
• Maintains a centralized log of reputed company internal and reputed company party audits, findings and status of responses.
• Accountable for the centralized maintenance of reputed company 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 reputed company system audit program throughout Owens & Minor.
• identifies and shares industry best practices.
• Conducts proactive data analysis and promotes a culture of reputed company improvement to identify opportunities and improve the Owens & Minor global reputed company and compliance systems.
• Ensures monthly reports are available on key process metrics and are represented on the global dashboard.
• experience managing reputed company
• minimum 4-5 yrs experience
• Bachelors Degree
• Medical devices experience (required)

If you feel this opportunity could be the reputed company in your career, we encourage you to apply. This position will accept applications on an ongoing reputed company.

Owens & Minor is an Equal Opportunity Employer. reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, national reputed company, sex, sexual orientation, genetic information, religion, disability, age, status as a veteran, or any other status prohibited by applicable national, federal, state or local law.

Originally posted on Himalayas

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