Associate PMS - EMEA at Baxter International

San Ġwann, Northern Region, Malta

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical DevicesIndustries

Requirements

Preferred Bachelor level degree or equivalent
Able to work in an environment that is highly regulated by procedures and quality system
Good team-player but able to organize own work with autonomy
Good interpersonal/communication skills
Critical thinking
Computer skills: Basic MS Office (Word, Excel, PowerPoint, Outlook)
Fluent in English at all levels (writing/reading/speaking)

Responsibilities

Gather complaint information from local organizations/complainants
Assess complaint information to determine regulatory reportability; manage timeliness of Vigilance reporting and communication with authorities
Work with plant quality organizations, technical services and suppliers to coordinate complaint investigations
Provide training to applicable stakeholders
Identify and escalate safety issues to management
Assure consistency of complaint records
Prepare complaint closure responses
Maintain compliance to regulations and procedures
Create reports
Coordinate Competent Authority (CA) requests
Initiate Nonconformance records
Work on Post Market Surveillance requirements as part of the EU Medical Device Regulations (Post Market Surveillance Plans; Post Market Surveillance Reports; Periodic Safety Update Reports (PSURs); Clinical Evaluation Reports (CERs))
Manage product complaints per documented procedures and assess regulatory reportability of received complaints
Coordination of complaint investigations and results with multiple stakeholders
Provide support in other Post Market Activities such as CERs, PMS Plans etc

Skills

Post Market Surveillance

Complaint Management

Vigilance Reporting

Regulatory Reportability

Complaint Investigation

CER

PMS Plans

Nonconformance Records

Regulatory Compliance

Report Creation

Baxter International

Provides essential medical products and services

About Baxter International

Baxter International provides a wide range of medical products and services essential for healthcare. The company operates in several areas, including critical care, hospital care, nutritional care, renal care, and surgical care. Its products are used in various settings, from emergency rooms to home healthcare, helping to meet the needs of patients and healthcare professionals. Baxter develops, manufactures, and distributes medical devices, pharmaceuticals, and biotechnology products, generating revenue through sales to healthcare providers and institutions. A key aspect that sets Baxter apart from competitors is its recent acquisition of Hillrom, which enhances its ability to offer comprehensive healthcare solutions. The company's goal is to improve care outcomes and increase access to healthcare through continuous innovation and a focus on patient needs.

Deerfield, IllinoisHeadquarters

1931Year Founded

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Health Insurance

Dental Insurance

Life Insurance

Disability Insurance

Health Savings Account/Flexible Spending Account

Unlimited Paid Time Off

Paid Vacation

Paid Parental Leave

401(k) Retirement Plan

401(k) Company Match

Employee Stock Purchase Plan

Commuter Benefits

Mental Health Support

Risks

Needle-free injection technology could disrupt Baxter's traditional injection-based therapies.

Shift to home healthcare may require Baxter to adapt its product offerings.

Growing digital health importance necessitates further investment from Baxter to stay competitive.

Differentiation

Baxter's acquisition of Hillrom enhances its comprehensive healthcare solutions portfolio.

Strong focus on patient-centric innovation sets Baxter apart in the healthcare industry.

Baxter's partnerships, like with Ayogo, leverage digital health for improved patient outcomes.

Upsides

Baxter's investment in Medically Home aligns with the growing home healthcare market.

Rising demand for personalized medicine offers Baxter opportunities for targeted therapies.

Expansion in telehealth supports Baxter's integrated healthcare solutions strategy.

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