Head of Postmarket Surveillance, Oral Healthcare

Job Title

Job Description

Head of Postmarket Surveillance Oral Healthcare

In this role you

You are responsible for overseeing all aspects of post-market surveillance including process implementation complaint handling and corrective and removal activities.

Your role:

• Drive monitoring support enhancement and implementation of post-market surveillance complaint handling and correction and removal processes and activities ensuring compliance with regulatory standards and organizational policies.
• Drive cross-functional periodic reviews and collaboration with stakeholders integrating feedback and lessons learned into product development and improvement processes improvements and strategic initiatives.
• Analyze and refine key operational metrics and reporting systems and ensure data-driven decision-making for continuous improvement. Lead and oversee quality metrics for trending purposes and reports on trending post market surveillance activities periodic safety reports etc.
• Lead investigations into product complaints and adverse events ensure timely reporting accurate triage escalation and resolution and oversee corrective/removal actions to maintain product safety and regulatory compliance.
• Lead manage and develop a multidisciplinary team. Foster a culture of transparency and accountability mentoring team members and ensuring the effective transfer of knowledge and best practices throughout the organization.

Youre the right fit if:

• Bachelors / Masters Degree in Medical Sciences Healthcare Management Industrial Engineering Supply Chain Management or equivalent.

• 5 years of experience with Bachelors OR Minimum 3 years of experience with Masters in areas such as Post Market Surveillance Operations Medical Device Quality Assurance Quality Control Clinical Research or equivalent.
• Preferred experience in Risk management experience for medical devices with thorough knowledge of FMEAs and RMRs Minimum 3 years prior management or other relevant experience Experience with FDA inspection and/or ISO Audits NCR FSN and CAPA experience is a plus Experience in both medical and non-medical is a plus Working knowledge of cGMP FDA 820 QSR and ISO 13485 or other Quality Systems
• You must be able to successfully perform the following minimum Physical Cognitive and Environmental job requirements with or without accommodation for thisOffice/Remoteposition.

How we work together

We believe that we are better together than apart. For our office-based teams this means working in-person at least 3 days per week. Onsite roles require full-time presence in the companys facilities. Field roles are most effectively done outside of the companys main facilities generally at the customers or suppliers locations.

This is an office role.

About Philips

We are a health technology company. We built our entire company around the belief that every human matters and we wont 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.
• Learn more about our culture.

Philips Transparency Details

The pay range for this position in Bothell WA is $128520 to $180000 Annually.

The actual base pay offered may vary within the posted ranges 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.

Company relocation benefits will not be provided for this position. For this position you must reside in or within commuting distance to Bothell WA.

#LI-PHI

This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.

Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.