Regulatory Affairs & Quality Consulting Manager (20122917)

Regulatory Affairs and Quality Consulting Manager

From day one, experience our difference. Our management consulting team focuses on our clients' critical business needs. From strategy to operations and everything in between, our integrated solution approach is designed to help enable and manage growth, leverage resources, and mitigate costs and risks. At Plante Moran, we have a privilege of serving clients and providing consultative services as they face challenges and seek new opportunities.

Your role.

Your work will include, but not be limited to:

  • Global Regulatory Pathway Strategies for Devices/Active Implants, IVDs, Biologics, Therapeutics, and Combination Products
  • FDA QSR/EU MDD GAP Analysis and Continuous Improvement Planning and Implementation; CBP/ACS/OASIS/NOA/FDA CFGs/EU CFS Related Import/Export Consulting
  • Process/Packaging/Sterilization/Transportation Validation Studies
  • Complaint Handling/MDR/MedWatch Reporting and Compliance Assessments
  • Quality Management Systems Audits, Continuous Improvement Planning and Implementations
  • Labeling/Marketing Material Reviews, Health Hazard Evaluations (HHEs) and Recall Strategies, Health Authority Communications and Implementations
  • FDA Enforcement Response/Remediation Activities for 483s, WL and Consent Decrees
  • Commercialization and, Launch Planning and Implementation Activities
  • Product Development Design Control Process Implementation, Transfer and Design Improvement Change Control

The qualifications.

  • 7+ years of experience in regulatory affairs and quality within the medical device industry
  • 7+ years of experience in medical device quality engineering with a background in manufacturing engineering and/or process engineering, ASQ/CQE, preferred
  • Bachelor's degree in Science, Engineering or related field, preferred
  • Expert knowledge in FDCA, FDA QSR, EU MDD, and ISO 13485 requirements.
  • Working knowledge of ISO 14971, IEC 62304 and IEC 60601 series standards, preferred
  • Experience to include but not limited to: QS SOP development, PHA / risk management, and design control best practices to ensure compliant DHF, V&V, DMR transfers, working knowledge of FDA requirements for internal / supplier audits and FDA inspections and continuous improvement methodologies
  • Frequent travel throughout the region, with approximately 75% overnight travel

Our difference.

We are a nationally recognized public accounting, consulting, and wealth management firm, consistently ranked as one of FORTUNE magazine's "100 Best Companies to Work For," and "20 Best Workplaces in Consulting & Professional Services." At Plante Moran, we live by the Golden Rule, fostering a relatively "jerk-free" culture with the lowest staff turnover rate in the industry. Our supportive network of well-rounded professionals is excited to catapult your growth and help pave your pathway to professional excellence.

Apply now. Experience our difference.

This is an exempt position, so you may have to work hours that exceed the standard 40-hour work week.

Plante Moran is an Equal Opportunity Employer, committed to a diverse workplace.

Interested applicants must submit their resume for consideration using our applicant tracking system. Due to the high volume of applications received, only candidates selected for interviews will be contacted. Candidates must be legally authorized to work in the United States without sponsorship, with the exception of candidates that are bilingual in Japanese and English. Unsolicited resumes from search firms or employment agencies, or similar, will not be paid a fee and become the property of Plante Moran.

The specific statements above are not intended to be all-inclusive.

Keywords:

Med

Medical

Device

RA

Regulatory

Compliance

FDA

510(k)

510

Instruments

483

Pharma


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