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 contact 888-367-7223, option 5, for assistance.
In this role, you have the opportunity to
This role is critical to ensure timely and accurate implementation of direct customer and Key market supported customer notifications related to Corrections and Removals are completed on schedule. Completes monthly FDA status reports, continuously tracks, monitors, and supports responses to global inquiries in support of customer notification and Competent Authority reporting. Represents BU with various Philips level teams regarding processes affecting area of responsibility. Ensures audit ready documentation.
You are responsible for
- Responsible and accountable for quality and regulatory activities supporting post-market regulatory activities, specifically regarding product recalls.
- Coordinate with Project Managers the development and maintenance of customer lists and accurately report on their status working with Project Managers and cross functional team.
- Track and maintain evidence of the accurate & timely delivery of customer communications to domestic and international customers working with global market personnel, and report on their status by via defined monitoring processes.
- Coordinate with team to actively drive the timely implementation of recall actions and monitor status by tracking implementation.
- Support in ownership of the recall documentation and maintenance.
- Ownership of timely and accurate responses to inquiries from USA and global regulators.
- Interact with diverse persons inside the company such as key market quality & regulatory contacts, customer support and field personnel in order to ensure that the product recalls are addressed according to established procedures.
- Ensure the effective delivery of customer mailings/communications and prepare the monthly status reports for effectiveness check.
- Ensure that the appropriate procedures and processes are followed in order to be compliant.
- Ensure managed areas are fully prepared for the audits and any inspections.
- Achieve the above goals by influencing & effectively communicating with Post Market Project Managers, Post Market Mgmt. and Field Sales and Services as appropriate.
You are a part of
As a result of Philips renewed commitment to Quality, it has recently restructured its organization to ensure you and your department have clear interfaces with Philips Business Group and Market leadership, and can harness the expertise of five Centers of Excellence (COEs). These 5 COEs specialize in the following capabilities: Regulatory & Clinical Affairs, Supplier Quality, Quality Management System, Quality Assurance & Engineering, and Compliance & Audit. As part of this new structure, you are empowered to use your voice and expertise to have a positive impact on your team, our business, and health technologies that will improve the health, well-being and care for people around world.
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’s Degree in scientific, health care, nursing or related field, or equivalent work experience
- Experience in a medically regulated and technical environment in (FDA Class I or II equivalent) preferred
- Problem Solving, working independently with minimum supervision
- Must be able to create custom reports within MS Excel to process data for management reporting
- Proficiency using office tools such as Microsoft Access and Excel, ClearQuest, and various other computer software applications
- Good Verbal and written communication skills
- Analytical skill and focus on detail, problem solving.
- Requires the proven ability to consistently meet and/or exceed goals. Must be capable of making commitments, setting priorities, and delivering results on time.
- Ability to work cross-functionally and within a global team.
- Able to exercise sound judgment within Philips using standard operating procedures and policies to determine appropriate action to achieve objectives.
- Must be able to work under pressure to meet regulatory reporting time frames and company requirements.
- Strong sense of responsibility and self-motivation with demonstrated ability to function independently and in a group environment.
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.