Philips Post Market Surveillance EU MDR Specialist in Andover, Massachusetts

null

In this role, you have the opportunity to

Help build compliance to EU MDR regulations in a high growth business that will help improve the lives of millions of people while advancing Philips journey as a global leader in Health Technology.

You are responsible for

  • Work with Post Market surveillance team to meet the requirements in generating PMS and PMCF reports as required.

  • Able to generate and extract Post Market Surveillance data necessary for making PMS and PMCF reports

  • Able to interpret and analyze clinical and Post Market Surveillance data

  • Provide and contribute as necessary to work with a cross-functional team working on the EU MDR requirements and reports to be submitted

  • Support internal and external audits.

  • Teamwork is embraced and highly regarded. Enforce and comply with the Philips Quality processes.

  • Identify product characteristics and/or failures that could lead to a death or serious injury

  • Assist Post Market Surveillance team and Complaint investigators as necessary.

  • Develop and maintain support systems knowledge including SAP, Clarify, OneEMS and Trackwise.

  • Utilize creative problem solving techniques.

  • Consistently being available to support our team in meeting all business objectives.

You are a part of

The Post Market Surveillance Department of Medical Consumables & Sensors, which is creating a new exciting opportunity to support Philips’ transition into the EU MDR regulated environment. The European Medical Device Regulation (EU MDR) ensures high standards of quality and safety for medical devices being produced in or supplied into Europe. Similar to the FDA’s UDI, MDR will establish a robust, transparent, predictable and sustainable regulatory framework for medical devices to ensure a high level of health and safety whilst supporting innovation. You will have exposure to a multitude of indications, medical devices, and workflow solutions.

In October 2013, we announced the creation of the ‘Medical Consumables & Sensors’ (MCS) Business Innovation Unit (BIU) that combined the existing Consumables business with the Children’s Medical Ventures portion of the Mother and Child Care Business Program. This new comprehensive business innovation unit specializes in the accessories, supplies and enabling technologies that accelerate strategic portfolio growth for Monitoring & Analytics and Therapeutic Care.

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

  • BS in a technical discipline or equivalent education, experience, training

  • 1+ years’ experience in the Medical Device, and/or other regulated industry (Pharma, IVD).

  • Basic knowledge of QSR, 21 CFR part 803, 820, ISO13485, Med Dev, ISO9001, etc.

  • Ability to query data/analyze data

  • Analytical skill and focus on detail

  • Teamwork in and outside Q&R

  • Utilize creative problem solving techniques.

  • Quality and/or Regulatory experience in a medically regulated and technical environment preferred

  • Demonstrated strong organization skills

  • Must be able to work under pressure to meet process/project time frames and company requirements.

  • Strong sense of responsibility and self-motivation with demonstrated ability to function independently and in a group environment.

  • Able to exercise sound judgment within Philips using standard operating procedures and policies to determine appropriate action to achieve objectives

  • Good Verbal and written communication skills

In return, we offer you

A path towards your most rewarding career. Succeeding in this 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.

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 at http://www.philips.com/b-dam/corporate/corporateblog/2016/PhilipsChronicDisease_5.jpg . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.

To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page at http://www.philips.com/a-w/careers/healthtech/working-at-philips/working-at-philips.html on our career website, where you can read stories from our employee blog at http://www.usa.philips.com/a-w/our-people/life-at-philips.html . Once there, you can also learn about our recruitment process at http://www.philips.com/a-w/careers/healthtech.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .

It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to age, color, citizenship, disability or perceived disability, ethnicity, gender, gender identity or expression, genetic information, marital or domestic partner status, military or veteran status, national origin, pregnancy/childbirth, race, religion, sexual orientation, or any other category protected by federal, state and/or local laws. Philips is an equal employment opportunity and affirmative action employer Disability/Veteran.

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.

#LI-PH1