Data & Documentation Remediation Specialist (Remote)
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Role details
Tech stack
Job description
· Review, organize, and maintain product safety, compliance, and technical documentation across systems such as PLM, network folders, and enterprise platforms.
· Establish and maintain centralized indexes and tracking tools for Biological Evaluation Reports (BERs), Life Cycle Management (LCM) records, and supporting documentation.
· Assess documentation for completeness, accuracy, template compliance, document age, rebranding status, test report availability, packaging information, and composition data.
· Identify documentation gaps, obsolete records, technical debt, and opportunities for consolidation or retirement.
· Conduct detailed gap assessments by comparing current documentation and data against applicable SOPs, standards, and future-state requirements.
· Develop prioritization frameworks, remediation plans, and tracking tools to provide visibility into documentation and data cleanup progress.
· Update, migrate, standardize, and remediate product safety and compliance documentation to align with current standards and SOPs.
· Organize and analyze large datasets to identify data gaps, inconsistencies, and opportunities for improvement.
· Support information gathering related to packaging, raw materials, product composition, and other legacy product data.
· Support targeted cleanup and rebranding activities within systems such as CDMS, PLM, and SAP S/4.
· Prepare compliance reports and perform associated data analysis as needed.
· Communicate documentation and data gaps clearly, prioritize workload, and collaborate with cross-functional teams.
· Work independently with minimal supervision while sharing best practices and contributing to process improvements.
Requirements
· Bachelor’s degree in Science, Engineering, Regulatory Affairs, Quality, Product Stewardship, or a related scientific discipline.
· Strong experience preparing, maintaining, organizing, and managing technical documentation, databases, spreadsheets, or compliance records.
· Hands-on experience with data management, including relevant data management tools or software.
· Demonstrated ability to organize and analyze large datasets and perform detailed gap assessments.
· Strong proficiency with Microsoft Excel and Microsoft 365 applications.
· Excellent attention to detail and ability to identify documentation and data discrepancies.
· Strong written and verbal communication skills.
· Ability to work independently with minimal direction and manage multiple priorities.
· Ability to interpret SOPs, standards, and requirements and translate them into practical documentation and data-management activities.
Preferred Qualifications
· Experience within the medical device, pharmaceutical, healthcare, regulatory, quality, or other regulated industry.
· Familiarity with product stewardship documentation, including Biological Evaluation Reports (BERs), Life Cycle Management (LCM), product safety, risk management, or regulatory compliance.
· Experience with PLM, SAP/SAP S/4, CDMS, document management systems, or similar enterprise platforms.
· Experience supporting EHS, compliance, quality, or product stewardship programs is a plus.
· Environmental Specialist experience is not required; candidates with strong documentation and data management backgrounds are encouraged to apply.
About the company
Russell Tobin is partnering with a leading medical device and healthcare organization to identify a Product Stewardship Data & Documentation Remediation Specialist for a remote opportunity, with preference for candidates local to Minnesota., Russell Tobin is a professional recruitment and staffing advisory firm that connects job seekers and employers across various industries. We are a staffing arm of Pride Global. Affiliates include Russell Tobin, Pride Health, Pride Now and Pride One.
For workers in the United States, PrideGlobal and it’s affiliates offers eligible employee’s comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance and hospital indemnity), 401(k)-retirement savings, life & disability insurance, an employee assistance program, legal support, pet insurance and employee discounts with preferred vendors.
Equal Employment Opportunity
PrideGlobal and it’s affiliates are an equal opportunity employer. We do not discriminate on the basis of the race, religious creed, color, national origin, ancestry, physical disability, mental disability, reproductive health decision making, medical condition, genetic information, marital status, sex, gender, gender identity, gender expression, age, sexual orientation, veteran or military status, or any other characteristic protected by applicable federal, state, or local law.
Fair Chance Employment
PrideGlobal and it’s affiliates are a Fair Chance employer. We consider all qualified applicants, including those with criminal histories, in a manner consistent with applicable state and local Fair Chance laws and ordinances, including, the California Fair Chance Act and all applicable local Fair Chance ordinances.
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