Looking at the challenges the world is facing today Philips’ purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you’ll be working towards creating a better and fairer future for all.In this role you have the opportunity toHelp transform Post Market Surveillance (PMS), which will help improve the lives of millions of people while advancing Philips’s journey as a global leader in Health Technology.Your role:
Work with a variety of diverse persons within the company such as Complaint Investigators, Complaint Handling Business Experts, Clinical Experts, Complaint Handling Market Experts, Vigilance Reporting Specialists, Engineers, Scientists, Field Service & Application Engineers, and Manufacturing personnel to facilitate and develop responses to inquiries from regulators and competent authorities in accordance with written procedures and global requirements.
Coordinate with Complaint Handling Business Experts and Level 3 complaint investigators to determine the need for information required for the drafting of inquiry responses.
Collaborate with Complaint Handling Business Experts, Clinical Experts, Complaint Investigators, and other business representatives to prepare responses to regulators and competent authority inquiries when needed.
Provide review of complaint to ensure all information needed for inquiry responses is present; determine if further investigation is needed and track investigation to conclusion.
Write, track, and submit inquiry responses to the necessary authorities. Monitor and improve tracking/control systems for regulatory inquiry responses.
Perform intake of new inquiries by logging data into tracker, complaint, Teams, and SharePoint.
You're the right fit if:US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
You have a bachelor’s Degree or higher in biomedical engineering, science, healthcare, or medical profession (Associate’s degree may be considered for individuals with at least 5 years hands-on patient care experience or experience with servicing or supporting the product(s) or similar product(s) in the field).
You have 2-5 years previous experience working as a biomedical engineer/risk manager OR in a licensed/certified capacity in a health care role such as an RN, NP, PA, MD, (Respiratory Therapist, Radiation Technologist, Ultrasound Technologist, CT technologist, EMT, etc. may be considered if applicable to product being supported) OR previous experience with servicing or supporting the product or comparable products in the field OR previous experience developing responses to regulatory inquiries.
You have 4-6 years’ experience Medical Device and/or other regulated industry.
You have moderate understanding of CAPA, Corrections and Removals, as well as global medical device regulations, requirements, and standards such as 21CFR Parts 803, 806, and 820, ISO13485, ISO14971, and ISO9001.
You have a background in global post market surveillance regulations (21CFR, MDD93/42/EEC and other applicable global regulations).
Your skills include great attention to detail, excellent writing skills, problem solving, ability to communicate issues in a timely manner, proficiency in Microsoft Office applications. Experience with Philips medical devices, Trackwise Complaint Handling Tool and Salesforce are a plus.
You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position (https://www.careers.philips.com/na/en/office/remote-sedentary-work-physical,-cognitive-and-environmental-pce-job-requirements) .
About PhilipsWe are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.
Learn more about our business (https://www.philips.com/a-w/about.html) .
Discover our rich and exciting history. (https://www.philips.com/a-w/about/our-history.html)
Learn more about our purpose. (https://www.philips.com/a-w/about/environmental-social-governance/our-purpose)
Read more about our employee benefits (https://www.careers.philips.com/na/en/best-employee-benefits) .
If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here (https://www.careers.philips.com/global/en/diversity-and-inclusion) .Philips Transparency DetailsThe pay range for this position is $74,000 to $136,000, Annually. The actual base pay offered may vary depending on multiple factors including, job-related knowledge/skills, experience, business needs, geographical location, and internal equity.In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here (https://www.careers.philips.com/na/en/best-employee-benefits) .At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.Additional InformationUS work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.#LI-PHI#LI-HYBRIDIt 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.Equal Employment and Opportunity Employer/Disabled/Veteran