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Corrections & Removals Specialist
Location:
US-CA-San Diego
Jobcode:
2493014
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Job TitleCorrections & Removals Specialist
Job Description
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, youll be working towards creating a better and fairer future for all.


In this role you have the opportunity to

Monitors and coordinates recall/field corrective action programs for medical and consumer products. Prepares required documentation of field actions (e.g., Health Hazard Evaluation documents, Correction and Removal documents, and product recall files).


Your role:


Support the field action process for IGTD including initiation, customer and regulatory notifications, and product correction or removal.
Work with cross-functional team to support development of required documentation of field actions.
Assist with preparation of customer letters, field action status reports, and communications to regulatory agencies and competent authorities for field actions.
Support Issue Impact Assessments (IIAs) and Health Hazard Evaluations (HHEs) to ensure risk assessment and analysis are consistent across products and systems within IGTD.
Complete activities in alignment with field action strategies.
Assist with internal communications for correction and removal activities, including communications for senior company management, corporate law, corporate communications, service markets, and distribution partners.
Maintain electronic records of corrections and removals activities, including consignee lists, communications with regulatory agencies, Field Safety Notice deliveries, receipt of customer responses, status reports, and record closure.
Continuously tracks field actions and provide ongoing information to teammates as required.
Reports metrics on the efficacy and efficiency of Corrections and Removals processes.
Timely submission of Corrections and Removals KPIs for IGTD.


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.

Bachelors degree in healthcare or science fields.
3+ years of quality or regulatory experience in the medical device industry.
Strong written and oral communication skills are required.
Ability to work well independently and on teams in a busy department while managing multiple ongoing tasks and investigations simultaneously.
Problem-solving and proficient computer skills are required.
Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
Experience working in a broader enterprise/cross-division business unit model preferred.
Working knowledge of appropriate global medical device regulations, requirements, and standards preferred, such as 21 CFR Parts 803, 806, and 820, ISO13485, European Medical Device.
Directive (93/42/EEC), European Medical Device Regulation (EU MDR 2017/745 EU) Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169, Brazilian Resolution RDC 23, and Therapeutic Goods Act 1989.
Ability to work in a matrixed and geographically diverse business environment.
Multitasks, prioritizes and meets deadlines in timely manner.
Strong organizational and follow-up skills, as well as attention to detail.



About Philips


We 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.
Discover our rich and exciting history.
Learn more about our purpose.
Read more about our employee benefits.

If youre 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.


Philips Transparency Details


The pay range for this position is $52,000 to $108,000, 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.

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 Information

US 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.
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Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.

Philips

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