Prentke Romich GmbH

Director of Quality and Regulatory Affairs

Prentke Romich GmbH

full-time

Posted on:

Location Type: Hybrid

Location: Wooster • Ohio • United States

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Salary

💰 $107,000 - $133,000 per year

Job Level

Lead

About the role

  • Ensure a robust and compliant quality management system (QMS) aligned with ISO 13485, FDA/QMSR, EUMDR, and other applicable standards.
  • Provide leadership and oversight to personnel serving as primary contacts for external audits, assessments, and inspections, ensuring ongoing audit readiness.
  • Lead management review processes and ensure effective follow up on quality system performance and improvement initiatives.
  • Oversee interpretation and implementation of regulatory, legal, customer, and industry quality requirements.
  • Ensure effective and compliant training programs for employees at all levels on quality standards, procedures, and continuous improvement methodologies.

Requirements

  • Bachelor’s degree in Engineering, Quality Management, Compliance, or a related field required.
  • Minimum of five years of experience in regulatory affairs and quality management systems within medical devices or related industries required.
  • At least three years of experience working with a document control system required.
  • Demonstrated leadership and coaching skills with the ability to build and sustain a team-oriented culture.
  • Strong analytical, organizational, and problem-solving skills.
  • Advanced proficiency in Microsoft Office, particularly Excel, with the ability to analyze and present large datasets.
  • Ability to effectively delegate, prioritize, and coordinate a wide variety of activities.
  • In depth knowledge of medical device manufacturing compliance, quality systems, procurement, and shipping requirements.
  • Strong relationship building skills with clients, colleagues, and vendors/suppliers.
  • Excellent written, verbal, and interpersonal communication skills.
  • Self-directed with the ability to perform effectively with minimal supervision.
  • Collaborative team player able to work across all levels of the organization.
  • Adaptable and flexible in a dynamic, evolving environment.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
quality management systemISO 13485FDA/QMSREUMDRregulatory affairsdocument control systemdata analysiscontinuous improvement methodologiesquality standardsmedical device manufacturing compliance
Soft Skills
leadershipcoachinganalytical skillsorganizational skillsproblem-solving skillsrelationship buildingcommunication skillsdelegationprioritizationcollaboration