Senior Manager - Corrections & Removals

Job Title

Senior Manager - Corrections & Removals

Job Description

The Senior Manager-Corrections & Removals (C&R) will utilize Quality expertise and Leadership abilities, managing a team of Corrections & Removals specialists performing recall reporting, tracking, and process execution, as well as managing the C&R review board agenda and facilitating C&R decisions, playing an important role in ensuring Product Quality and Patient Safety.

Your role:

• Identify affected products/customers and countries. Determine: resolution to correct and/or remove affected product(s), effectiveness check/closure strategies, C&R reportability and country reporting applicability. Define: scope/depth of the C&R, product disposition strategy and the C&R action team members.
• As a member of the Post Market Surveillance organization, you will collaborate with the Sleep & Respiratory Care business and Philips Q&R Market representatives to accurately track and document field corrective actions and Support the Post Market Surveillance group with Competent Authority requests.
• This Hybrid role, may require travel up to 10%.

You're the right fit if:

• You've acquired 7+ years' experience in FDA Regulated Post Market Surveillance (PMS), with a focus in Recalls, Corrections and Removals (21 CFR Part 820 (QSR), Part 7, 806, 810).
• Your skills include proven functional/strategic leadership of Post Market Surveillance teams, detailed knowledge in FDA and Global Medical Device regulations, strong communication/collaboration skills and a commitment to excellence, with strong attention to detail.
• You have ensured accurate and on time tracking of open SCR Field Actions on a monthly basis and created documents identified in C&R strategies.
• You have a minimum of a Bachelor's degree (required), in a Quality, Regulatory, Technical or Scientific discipline; Advanced degree (preferred).
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position
• You're a self-starter with strong organizational leadership skills and skilled in driving continuous improvement in a matrixed environment, with the capacity to adapt to changing work requirements as needed.

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 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.

Philips Transparency Details:

The pay range for this position is $96,000 to $178,000, 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.

All United States-based employees are required to be fully vaccinated against COVID as a condition of employment at Philips*. Employees may request a reasonable accommodation. *Montana employees, learn more here.

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