Open Position: Regulatory Affairs & Quality Assurance Manager


INRAD is a medical device developer, manufacturer and distributor seeking a Regulatory Affairs & Quality Assurance Manager. Reporting directly to the President, this position is responsible for all areas of Regulatory Affairs & Quality Assurance.


Job Responsibilities

  • Act as Management Representative
  • Ensure quality system requirements are effectively established and effectively maintained.
  • Report on the performance of the quality system to management with executive responsibility for review.
  • Assist with establishing quality policy and quality objectives.
  • Assist with ensuring that the quality policy is understood, implemented, and maintained at all levels of the organization.
  • Maintain and continually develop INRAD quality systems, processes, and infrastructure to ensure compliance, effectiveness and continual improvement. Provide training when needed.
  • Establish and drive successful fulfillment of strategy and objectives for the Regulatory Affairs & Quality Assurance Department. Monitor and report on progress to these objectives.
  • Managing the daily activities of Quality Assurance personnel and maintaining acceptable morale in the QA department.
  • Providing training and/or job coaching to Quality Assurance Technicians.
  • Lead representative for INRAD for all regulatory and third-party quality system audits (i. e. FDA, ISO, Supplier Quality, etc.).
  • Conducting internal audits and audits of suppliers as needed.
  • Determine regulatory pathways for various projects including product classification and type of regulatory submission or rationale required.
  • Prepare and manage regulatory submissions to the FDA, the Notified Body, Health Canada, and other applicable regulatory authorities.
  • Liaison activities with regulatory bodies, suppliers, external consultants, and other third parties on RA/QA matters.
  • Oversight and review of design control, process and design verification and validation activities in collaboration with Engineering & Operations teams.
  • Ownership and administration of regulatory and quality document control systems, including writing, reviewing and approving controlled documents.
  • Initiating and investigating complaint, variance, corrective and preventive activities and taking appropriate actions as needed.
  • Administration of various quality system activities including but not limited to:
    • Identifying and addressing additional training needs.
    • Management of the INRAD preventive maintenance system
    • Reviewing and approving Sterilization Load folders for release
    • Management of sterilization validation activities
    • Reviewing and approving device history record documentation
    • Review and approving suppliers; maintaining approved supplier documentation
    • Material Review Program
    • Calibration system and scheduling
    • Corrective Action and Preventive Action System (CAPA)
    • Medical device reporting and vigilance reporting system
    • Microbial, Particulate and General Documentation review and approval system
    • Label and Labeling review and approval functions
    • Various other GMP and ISO Compliance activities
  • Additional projects as assigned by the President


Job Details

  • This position is in-person, onsite in our Kentwood, MI office
  • Occasional Travel – Less than 10%


Job Knowledge, Education and Experience Requirements

  • Four (4) year college degree or higher
  • Minimum five (5) years work experience in FDA regulated facility (or equivalent)
  • Previous Management experience
  • Demonstrated knowledge of US FDA regulations, the MDD/MDR, Canadian Medical Device Regulations, and various quality system standards/regulations/laws, including but not limited to 21 CFR 820, ISO 13485, etc.
  • Demonstrated experience in developing, implementing, and managing process quality controls, design and development of training programs.
  • Internal / External audit experience
  • ISO regulated industry experience medical device related
  • Additional RA/QA training preferred
  • Additional management / leadership training preferred
  • Clean room experience preferred


Skills and Competencies

  • Demonstrate a high level of honesty and integrity
  • Skilled at managing ambiguity, influencing without authority and achieving results
  • Strong interpersonal skills
  • Ability to influence and impact positive organizational change
  • Self-motivated with the ability to prioritize tasks and work effectively with others
  • Understand Good Manufacturing Processes (GMP’s)
  • Ability to read, understand, and follow specifications
  • Ability to follow verbal and written instructions
  • Understanding tolerances and variations
  • Understand Production methods, manufacturing techniques, statistical methods
  • Ability to multi-task proficiently
  • Demonstrate excellent judgment and analytical skills
  • Proficient computer skills
  • Data collecting and charting / reporting
  • Performing multiple tasks with minimal / no supervision
  • Strong communication skills (written and verbal)
  • Strong attention to detail
  • Ability to adapt to changing environment/priorities
  • Ability to manage and lead others
  • Proficient, organized Management skills
  • Ability to read / understand reports and provide evaluation / feedback
  • Ability to lead audits with minimal assistance
  • Excellent customer service skills
  • Proficient mathematical skills
  • Able to read drawings
  • Ability to use measuring devices/hand tools

Physical Requirements

  • Good vision
  • Good hand-eye coordination
  • Able to lift 25 lbs
  • Able to sit or stand for four (4) hours at a time
  • Moderate twisting, bending, and lifting
  • Able to travel on occasion
  • Able to work with / assemble small components

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