Director of Regulatory Affairs & Quality Assurance (Medical Device)
Coyote Technical & Executive Sourcing
Fairfield, CT
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
About the Company
Coyote Technical & Executive Sourcing
Who Are We?
Coyote Technical is a full-service staffing and recruiting firm that provides services in temporary, contract and permanent placements. Coyote Technical can provide you with superior employment services, focusing on sourcing quality candidates with the exact education and experience you need. Phil Montoya, Director of Sourcing, has years of recruiting experience in diverse industries. His status as Top Recruiter with most successful placement is testimony to his relentless pursuit of the perfect candidate. Phil holds a BS in Mechanical Engineering and worked for years in the Automotive and Aerospace Industries. Coyote Technical’s recruiting Team is equally committed to finding the talent you seek. Our years of experience enables us to intimately understand your industry, thereby we will provide you with quality and effective employment services.
Why Choose Us?
Coyote Technical aims to fill every position you list by matching the ideal candidate with the ideal position. Coyote technical has an ever-expanding internal database of more than 20,000 candidates with the skills and qualifications to match any of your hiring needs. It is our mission to ensure that every candidate be placed in a position in which they will thrive professionally.
Our fees are contingent upon finding you the perfect candidate, which means you will not pay a fee unless we are successful. In fact, we will extend a thirty (30) day guarantee. Should the candidate leave or be terminated for cause within the first thirty (30) days from the starting date the candidate will be replaced. What does this mean for you? Peace of mind in knowing that you will have an employee with the competence and enthusiasm you desire!