Manager, Standards Compliance

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Job Function:
Quality

Job Sub Function:
Quality Systems

Job Category:
Professional

All Job Posting Locations:
Warsaw, Indiana, United States of America

Job Description:

The Manager, Standards Compliance provides leadership for ensuring manufacturing operations remain aligned with applicable standards, regulations, and internal policies.

This role oversees the monitoring and tracking of emerging regulations and standards, and changes impacting the business.

The position has a direct impact on product quality, patient safety, audit readiness, and operational excellence and partners closely with Manufacturing, Quality, Engineering, and Regulatory teams.

Key Responsibilities


* Design, development and implementation of the standards management process within the regulatory intelligence program.


* Own and facilitate the regulations and standards change management and assessment process.


* Monitor regulatory changes throughout the product lifecycle with specific focus on regulations and standards associated with the QMS and regulatory filings.


* Development, tracking and trending of metrics for the standards management process


* Interpret external standards, regulations, and internal quality requirements and translate them into production‑ready processes and controls.


* Facilitate the assessment of regulations and standards changes by partnering with subject matter experts to ensure compliant implementation.


* Support internal and external audits, inspections, and assessments related to the standards compliance process.


* Provide guidance, training, and oversight on the process and platform.


* Drive continuous improvement initiatives to strengthen compliance, consistency, and operational effectiveness.

Qualifications
Education:


* Bachelor's degree in Engineering, Quality, Life Sciences, Manufacturing, or a related discipline (required).

Experience and Skills:
Required:


* Typically 6-8 years of progressive experience in manufacturing quality, regulations and standards compliance, or related roles with deep knowledge of applicable regulatory requirements.


* Strong working knowledge...