Director of Quality Assurance and Regulatory Affairs

This position serves as the head of the Quality Management and Regulatory Affairs team and leads, manages, and supports all medical device Quality System and Regulatory activities. Serves as Management Representative and Person Responsible for Regulatory Compliance (PRRC)

Responsible for:

• Manage the site Quality Management System including: management reviews, complaint internal auditing, training and manufacturing support.
• Ensures compliance with DemeTECH Quality Policies, cGMP, ISO, MDD/MDR, MDSAP quality systems requirements.
• Review and approve all quality system documentation including but not limited to:
  Standard Operating Procedures (SOPs), Work Instructions (Wls), Forms, Validation Protocols and Reports, Device Master Records, Product Labeling and Specifications.
• Review and approve all Qualification and Validation Protocols and Reports.
• Coordinate QMS certifications (ISO, MDSAP, MDD/MDR) and maintenance.
• Guiding the management team to ensure that operations are within the required regulatory guidelines for products from a final product acceptance and compliance perspective.
• Maintain quality system performance metrics.
• Ensure conformity of the device to the manufacturer's QMS prior to release.
• Ensure technical docurnentation and EU Declaration of Conformity (DoC) are current.
• Ensure effective transfers of new products into production that meet all Quality requirements for the classification.
• Conduct the Management Review, providing reports of tracking of Quality Metrics to Top Management.
• Authorize the rework of non-conforming product and conduct the material review and disposition at the completion of the rework. Evaluates whether product does or does not meet all specifications and requirements prior to final release.
• Oversee the environmental monitoring program.
• Evaluate returned product and dispositions product.
• Notify Management of any Product Quality issues and major deviations.
• Conducts product recalls and/or vigilance repotting
• Oversee/perform internal audits and audits of external suppliers and service providers.
• Host external auditors, customers and regulatory inspections including FDA and foreign regulatory
• Oversee and maintain Supplier Qualification Program.
• Manage communication with all economic operators.
• Conformity of devices with QMS and regulatory requirements before market release.
• Technical documentation, labeling, and EU Declaration of Conformity (DoC) are maintained and updated in compliance with MDR/IVDR and FDA regulations.
• Post-market surveillance and vigilance reporting, including adverse event reporting, product recalls, and field safety corrective actions (FSCA).
• Compliance with import/export regulations and communication with Notified Bodies, Competent Authorities, and FDA.
• Oversight of economic operator requirements (e.g., authorized representatives, distributors, and importers) for international regulatory compliance.
• Alignment of Regulatory Intelligence with changes in FDA, EU MDR, and ISO 13485 to proactively manage compliance risks.

Competencies and Educational Requirements

Education:

BS Chemistry, Biology, Biomedical Engineering, or similar scientific/technical field. Working

knowledge of cGMP, ISO 13485, and EU Medical Dev;ce Directive (MDD)/Regulations (MDR). Fluent in

English. Spanish is a plus.

Communication skills:
Position involves contacts with individuals inside and/or outside the Organization

where the nature of the information provided usually follows an established pattern. Excellent verbal and

Results Driven, Mathematical Skills, Technical Capacity, Thoroughness, Time Management.

Judgment and Decision Making:
Collect, interpret, and/or analyze complex data and information.

Demonstrated proficiency in supervising and motivating subordinates. Proven ability to handle multiple

projects and meet deadlines.

Experience:

Minimum of 5-10 years regulatory/quality assurance or quality engineering supervisory

experience in an FDA registered facility for medical device manufacturing. Requires thorough

knowledge of FDA Quality System Regulation (QSR) experience for medical device

manufacturing. Knowledge of the Medical Device regulations and their appropriate application is

needed to assure compliance with regards to manufacturing.