Department: Regulatory Affairs & Quality Assurance

Job Summary:

Under the direct supervision of the President, this position is responsible for all areas of Regulatory Affairs & Quality Assurance.

Main Responsibilities:

This position at INRAD Inc. entails numerous responsibilities including, but not limited to the following:

  • 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, HealthCanada, and other 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 and reviewing 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 Preventative 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

Education:

  • Four (4) year college degree or higher

  • Additional RA/QA training is preferred

  • Additional management/leadership training is preferred

Job Experience:

  • Minimum of five (5) years of 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

  • Clean room experience preferred

Skills / 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 50 lbs

  • Able to sit or stand for four (4) hours at a time

  • Able to work with / assemble small components

  • Moderate twisting, bending, and lifting

  • Able to travel on occasion