Vice President of Quality/Regulatory

Mundelein Permanent USD160,000 - USD180,000
  • Oversee Quality/Regulatory team, established Medical Device Manufacturer
  • Incredible benefits, including remote work, bonus and 8% 401k match

About Our Client

Our client is an established Medical Device Manufacturer that has been in business for over 100 years. They seek a Vice President of Regulatory/Quality that will report to the Executive Vice President. Their site has over 175 employees, with a total of 225 throughout North America. Their products serve urology, surgery, gynecology and spine surgery.

Job Description

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

Description

  • Responsible for ISO 13485 compliant quality systems to that ensure maintenance of Certification
  • Establish appropriate organizational structure to ensure compliance with regulatory requirements and that effectively support operational objectives.
  • Responsible for directly interfacing with external authorities as needed for audits, inspections and other inquiries within the scope of applicable FDA, ISO 13485 and product safety standards.
  • Responsible for communicating direction for new FDA regulatory requirements, enforcement actions and other relevant FDA activities that impact the regulatory standing
  • Responsible for identifying and implementing appropriate training schedules for affected personnel for applicable FDA Quality System Regulations.
  • Responsible for ensuring effectiveness of the FDA Quality System Regulations by conducting periodic audits and review of quality data sources and recommending improvements to executive management.
  • Establish processes to ensure effective communication to identify product problems and implement appropriate changes as directed.
  • Establish processes to support the introduction of new products or changed into the US market in compliance with FDA pre and post market requirements.

The Successful Applicant

  • Bachelors Degree in related field
  • Minimum of 5 years of leadership experience in Quality Assurance/Regulatory Affairs within the medical industry
  • An expert understanding of the Federal Regulations concerning Medical Devices
  • Experience with and understanding of cross-cultural differences and the ability to work within this environment
  • Ability to write effective procedures that produces the required level of documentation without overly burdening resources and personnel
  • The ability to make appropriate, risk-based decisions to ensure product and process conformance to applicable requirements that support the operational objectives
  • Adequate organizational skills to manage and coach subordinates to peak performance
  • Familiarity with medical standards such as ISO, ANSI/AAMI and UL
  • The ability to work in a fast-pace environment as well as demonstrated decision-making abilities

What's on Offer

  • Competitive base salary depending on experience, between $160,000 and $180,000
  • Yearly bonus, based on metrics and performance circa $15,000
  • Car Allowance - $6,000/year
  • Comprehensive benefits including medical, dental and vision through BCBS
  • Flexible Spending Account
  • Life and AD&D Insurance
  • Disability Insurance
  • 401k Match - 3% Automatic Enrollment, 1% Annual Increase up to 6%, 2% Discretionary Match. Total of 11% Match
  • Tuition Reimbursement
  • Paid Parental Leave
Contact
Josh Berg
Quote job ref
JN-012022-4567501

Job summary

Sector
Engineering & Manufacturing
Sub Sector
Quality, Technical
Industry
Healthcare / Pharmaceutical
Location
Mundelein
Contract Type
Permanent
Consultant name
Josh Berg
Job Reference
JN-012022-4567501