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Job Description

Overview:

Insight Global is looking for a Corrections and Removals Project Manager to join one of our largest medical manufacturing companies in the Pittsburgh area. This role will ensure that processes for specifying and executing corrections and removal are adequate, ensures alignment with other processes (risk management, CAPA), and ensure the expectations of key stakeholders are met. Ensures adequate C&R oversight across top Management. This person will also ensure tools are available for efficient and effective C&R programs.

Day to Day:

- Lead the efforts to create the SOPs for new processes surrounding Correction and Removals of product recalls.

- Monitors and coordinates the different sub-system feeders to this process and ensures CRRB (Correction & Removal Review Board) input and decisions are timely.

- Prepares and manages key documents such as Health Hazard Evaluations, Correction and Removal documents, UAL/CAL, Regulatory Reports, Periodic Update Reports, Termination Requests, and various internal reports.

- Continuously track field actions and provide ongoing information on progress key business partners and to FCO team, Regulatory Operations teams as required.

- Provide actionable and insightful C&R analytics across the organization and Management

- Supports the development of process for specifying and executing C&R are adequate to ensure the expectations of local key stakeholders are met.

- Facilitates C&Rs by ensuring the coordination and or creation of C&R file documentation, C&R file completion and C&R responses.

- Prepares key documents such as Health Hazard Evaluation documents, product C&R files and various internal reports.

- Ensures alignment between risk assessment and management documentation and C&R files.

Monitor and report on metrics on the C&R KPI's and generation of periodic reports.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com .

To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/ .

Skills and Requirements

- Bachelors Degree

- 3+ years of experience within the professional world

- Experience from a highly regulated industry (Medical Device, Pharmaceuticals, government, etc.)

- Strong ability to provide clear and concise writing products

- Good communication & customer service ability / previous exp being sales / field / outreach facing - Basic understanding of medical device regulations

o ISO 13485, FDA QSR, 21 CFR 806

- PMP Certification null

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HR@insightglobal.com.