Director of Regulatory Affairs & Quality Assurance (Medical Device) - Coyote Technical & Executive Sourcing

Fairfield, CT

About the Job

Job Title: Director of Regulatory Affairs & Quality Assurance (Medical Device)

Division/Department: Regulatory Affairs and Quality Assurance

Reports to COO

Purpose/Summary:

Hands-on Director who is responsible for the Regulatory Affairs and Quality Assurance strategy, policies, and procedures to ensure we follow all domestic and international guidelines and regulations.

Responsible for delivering the highest quality product and meeting and exceeding customer's expectations.

Company’s Quality Management System Representative

Supervising: Quality Engineer, Customer Service Representative, Supplier Quality Engineer, Regulatory Affairs Specialist

Qualifications:

Will be responsible for developing FDA and ISO 13485 compliant QMS that is relevant to our business model. Including but not limited to Design Controls, Supplier Quality, Management Controls, Complaints process/MDR, Field Actions, CAPA, Internal Audit, etc.

Responsible for development of regulatory strategies that ensure compliance to US and International product registration requirements and clearance/approval.

Will be actively involved with the turn-key suppliers and responsible for Supplier Quality Assurance and Product Quality.

Will assist in medical affairs and clinical plans and trials

Provide assessments and recommendations on non-conforming and product quality issues and regulatory compliance.

Will review, edit and approve all Risk Management, Verification and Validation protocols, procedures, and reports.

Identifies, analyzes, and documents, problems and works with respective teams for proper resolution.

Conducts internal inspections and facilitates external inspections

Implementing monitoring and improvement processes including CAPA, customer feedback, and post market surveillance

Review and approve Marketing/Sales advertising and collateral materials ensuring regulatory compliance

Secure and maintain ISO 13485 certification

Will work directly with our Regulatory and Quality Assurance consulting teams

Education and/or Experience:

Minimum Education: Bachelor’s degree in engineering and/or business, or equivalent experience.

Minimum Experience: 15 years of Quality Assurance, Quality Engineering, and Regulatory experience in a FDA regulated environment, preferably Medical Devices, Gastrointestinal.

Minimum Field Expertise: 5 years of Regulatory experience with new product introductions and dealing with the FDA.

Preferred Field of Expertise: Turn-key supplier management of R&D and Production on hand held Medical Devices. Direct experience working with the FDA and external regulatory consultants. Technical emphasis should be with all types of plastic processes, cabling and small mechanical parts.

Essential Knowledge, Skills, and Abilities:

Proficiency in FDA regulatory requirements, quality assurance, risk management, verification and validation processes and ISO 13485

Can effectively work with our turn-key suppliers, R&D teams and is a hands-on type individual

Must be capable of writing policies, procedures, and audit reports

Position requires substantial domestic travel dealing with our partners and turn-key supply base

Language Skills, Software Skills, Analytical Skills, Mathematical Skills, Presentation skills, Team Player, ETC.

Excellent oral and written communication skills. Must be able to talk and communicate with FDA panels and auditors, along with regulatory consulting groups.

Strong analytical and mathematical skills

Creative thinker, collaborator, active listener and is not afraid to roll up his sleeves.

Effective time management and ability to work independently

No sponsorship visa (H1-B, etc) candidates at this time, sorry.

Qualified candidates must submit their resume in Microsoft Word format along with at least three professional references to:

COYOTE TECHNICAL & EXECUTIVE SOURCING
Phil Montoya
Director of Sourcing

Source : Coyote Technical & Executive Sourcing