Integer - Chaska, MN

posted 24 days ago

Full-time - Mid Level
Chaska, MN
Computer and Electronic Product Manufacturing

About the position

The primary purpose of this job is to strategically plan, execute and provide oversight to regulatory activities necessary to obtain and maintain regulatory approvals within the United States and International markets and ensure compliance with relevant FDA, EU, ISO, and other regulatory requirements and standards.

Responsibilities

  • Adheres to Integer Core Beliefs and all safety and quality requirements.
  • Develops US and International regulatory strategies for product submissions, identifying needs for bench, animal and clinical testing.
  • Provides strategic input and participates on Product Development teams, offering high-level experience in regulatory strategy, timelines, and direction.
  • Prepares US and International submissions and collaborates with government agencies and/or distributors to obtain product approval/clearance.
  • Serves as an informational resource for all departments, assisting in keeping the company informed of US and International regulatory requirements.
  • Ensures relevant International, ISO and FDA Export requirements are met and ensures accuracy of submission information.
  • Initiates FDA export approval requests and product release authorizations.
  • Reviews ECO's and assesses the effect of product changes on US and International regulatory strategy and submissions per standard procedures.
  • Evaluates post-market incident reports and determines MDR requirements.
  • Assists with recall/retrieval documentation and other activities.
  • Develops and maintains regulatory status documents and submission procedures.
  • Identifies, investigates, evaluates and implements new methodologies associated with product quality and quality systems.

Requirements

  • Bachelor's degree in a related field.
  • 7+ years of US and International medical device regulatory submission/approval experience, including FDA, MDD, PMDA, TGA, and TPD experience.
  • Knowledge of FDA Quality System regulations and ISO requirements.
  • Knowledge of all applicable laws which regulate medical device manufacturers.
  • Ability to work through difficult issues with suppliers and customers.

Nice-to-haves

  • Strong communication and technical writing skills.
  • Skill in management, precision measurement, auditing, training, supplier/customer relations, FDA inspections, ISO 9000.
  • Skill in working with computers and experience with spreadsheet and word-processing software.

Benefits

  • 401k
  • health_insurance
  • paid_holidays
  • tuition_reimbursement
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