Job description

Director of Quality and Regulatory

We are seeking a Director of Quality and Regulatory with an entrepreneurial spirit who excels in a dynamic, growth-oriented environment to join our team.

Responsibilities

• Lead development and execution of the QA/RA strategy, develop a roadmap to support organizational goals and provide guidance concerning quality system and regulatory requirements.
• Assess compliance with the corporate quality system that includes compliance with US FDA, and applicable international standards and regulations, and make necessary changes to maintain a high level of compliance with applicable standards and regulations.
• As part of QMS, will manage ongoing quality system activities including Management Review, Employee Competency & Training, Corrective Action and Preventive Action (CAPA), MRB activities, Internal & External quality system audits, Risk Management Evaluation, Product Development Design Controls
• Oversee various quality system records, including Device Master Records, Technical Files, and QA System Release Records.
• Develop and Maintain Post-Market Surveillance & PSUR reports.
• Leads or compiles all materials required in submissions, license renewal, and annual registrations.
• Define, develop, and manage various quality projects, validation studies, and monitoring to ensure compliance with global regulatory requirements.
• Oversee external third-party quality systems/regulatory audits and inspections, such as Notified Body and regulatory authorities.
• Support global regulatory compliance to distribution networks and OEM customers.
• Manage the device complaint handling system including, evaluation, coordination of investigations, maintenance of complaint records, and regulatory reporting of device incidents.
• Manage supplier qualification and oversight programs. Perform external supplier quality audits.
• Support QA/RA aspects of corporate ERP installation.
• Manage QA/RA aspects of medical device design and development process including compilation, review, and approval of device design history files, risk management reports, device master records, and device technical files, including the coordination of design verification/design validation.
• Adhere and execute to the core principles of process standardization, elimination of non-value-added activities, and the introduction of new value add processes.
• Keeps abreast of regulatory procedures and changes.
• Other duties as assigned.

Must Have: Minimum Requirements

Minimum of 4 years of medical device regulatory experience, or advanced degree with a minimum of 2 years medical device regulatory experience

Nice To Have

• Experience with 510(k) submissions
• Knowledge of FDA requirements
• Knowledge of EU requirements
• Experience with FDA requirements, guidance documents, Medical Device Directive, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards
• Product Labeling requirements and standards
• Technical Writing
• Systems Knowledge such as RA systems, management systems
• History of successful 510(k)/IDE/PMA device submissions and other worldwide submissions and clearances.

Job Type: Full-time

Pay: $80,000.00 - $120,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Referral program
• Vision insurance

Schedule:

• 4x10
• 5x8

Ability to commute/relocate:

• Millstadt, IL 62260: Reliably commute or planning to relocate before starting work (Required)

Experience:

• ISO 9001: 1 year (Preferred)

Work Location: One location

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