Job description

Regulatory Affairs Consultant / Correction and Removal Manager
(Role is remote, hours are 8AM-5PM, ET preferred)

12 Months with the possibility of extension and permanent to hire

JOB ID -PHHJP00021345

In this role, you have the opportunity to:
The Correction and Removal Manager will manage the execution of the correction and removal process. You will manage a local team and collaborate across functions to ensure process adherence and improvement.

You are responsible for:

• Oversee a team that manages Customer responses, C&R file documentation and C&R file completion.
• Monitors for and reports on metrics on the efficacy of C&R process.
• Provide ongoing information to C&R and Field Change Order team as required.
• Manage projects as related to interdepartmental systems and communications to improve process efficiency.
• Provides relevant feedback and insights from customers/field/engineering teams to ensure learnings from previous projects are captured, synthesized, and made available for next project teams.
• Manages regulatory agency updates as required.

You are a part of:
The Respironics Team is headquartered out of Pittsburgh, PA. We welcome you to join Philips HealthCare. The Quality and Regulatory team enables meaningful innovation for our customers by partnering with and guiding the business to achieve world-class quality and regulatory compliance in a rapidly changing environment, while creating a great workplace for our people to realize their career aspirations.

To succeed in this role, you should have the following skills and experience:

• At least 5 years managing teams.
• 4-6 years post-market surveillanceexperience in a medically regulated industry, with some experience in recallsdesired.
• Bachelor’s degree in engineering, clinical sciences, related sciences, or relevant related experience.
• Proficiency using office tools such as Microsoft Office Suite and various other computer software applications.
• Working knowledge of appropriate global medical device regulations, requirements, and standards such as ISO 13485 and ISO9001, and FDA QSR. Medical Device and or other healthcare regulated industry (Pharma, IVD,).
• An organized, analytical thinker with exceptional attention to detail.
• An excellent communicator, both written and verbal for coordinating with colleagues and regulatory authorities worldwide.
• Able to exercise sound judgment within Philips using standard operating procedures and policies to determine appropriate action to achieve objectives.

Job Types: Full-time, Contract

Salary: From $50.00 per hour

Schedule:

• Monday to Friday

Work Location: Remote

Speak with the employer
+91 +14695754108

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