Regulatory Affairs & Quality Assurance Manager
Department: Regulatory Affairs & Quality Assurance
Under the direct supervision of the President, this position is responsible for all areas of Regulatory Affairs & Quality Assurance.
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
Four (4) year college degree or higher
Additional RA/QA training is preferred
Additional management/leadership training is preferred
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
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