Complaint Investigator- Adverse Events

Job Description

Job Title

Job Description

If you are a Colorado resident and this role is a field-based or remote role, you may be eligible to receive additional information about the compensation and benefits for this role, which we will provide upon request. You may c ontact 888-367-7223, option 5, for assistance.

In this role, you have the opportunity to

Work with a variety of diverse personnel within the company such as Engineers, Scientists, Clinical Specialists, Field Service & Application Engineers, and Manufacturing personnel to facilitate the complaint handling process globally. Evaluate customer feedback, service records, and other sources of customer and internal for possible complaint and submit Medical Device Reporters or it’s equivalent to different Competent Authorities (MIR).

You are responsible for

• Completes initial assessment of reportability and escalates to manager to determine action, when necessary
• Analyzes complaint data, gathers additional data as needed, and partners cross functionally to provide feedback to the BIU supporting complaint evaluation and/or to the Market Management Review on potential process and quality improvements.
• Frequently interacts with subordinate supervisors and functional peer groups. Interaction normally requires the ability to gain cooperation of others, completing regulatory reports and submitting to Competent Authorities

You are a part of

In this role you will be part of the Post Market Surveillance team responsible for assessing and submitting regulatory reports to FDA and Competent Authorities. Exposed to a variety of international standards including new regulations (US) and reporting guidelines and the newest EUMDR process.

To succeed in this role, you should have the following skills and experience

• US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
• Bachelor degree in bio medical, engineering, healthcare, nursing or related technical degree with 0 - 1 years of experience; OR Bachelor degree with 1+ years of experience in a medical device or regulated industry.
• Basic understanding of global medical device regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO13485, and ISO9001.
• Medical Device or biomedical experience in undergraduate program or other related work experience
• Detailed oriented and time management skills is a must.

In return, we offer you

A path towards your most rewarding career. Philips is growing its marketing capability enterprise wide. Succeeding in this global role in a complex environment will open many doors for your long-term career, in other areas in Philips or otherwise. We also believe that we are at our best as a company when you are at yours as a person. Thus, we offer competitive health benefits, a flexible work schedule and access to local well-being focused activities. Furthermore, Philips University is available to all employees for learning and development opportunities.

Why should you join Philips?

Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video.

To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions.

It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person’s relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.

As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.

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