QA Regulatory Engineer job New York New York
QA Regulatory Engineer job New York New York
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QA/Regulatory Engineer Job



Employer Name: EIR NETWORK SpiderID: 8817314
Location: New York, New York Date Posted: 7/18/2019
Wage: 100,000 Category: Manufacturing
Job Code:
Number Of Openings: 1

Job Description:
Product Regulatory compliance

Lead teams in the preparation of documents and records necessary for regulatory compliance (FDA, CE, EU MDR, Health Canada) including risk analysis, MDR general safety and performance requirements, MDR classification, Device Master Records, Technical File, Declaration of Conformity, Clinical Evaluation, etc.

Manage/support organizational and product registrations and listings including FDA Device Establishment Registration, FDA product listings, Health Canada Device Licensing, EU MDR product lists.
Prepare FDA 510K pre-market clearance applications for new or revised products.

Support international partners with the registration of medical devices.

Interact with Notified Body during evaluations of Technical Files.

Prepare and submit vigilance reports for mandatory reporting incidents.

 Product Safety and Testing

o Oversee third party product testing to applicable device standards (IEC 60601 series).

o Maintain North American NRTL safety mark by assuring appropriate production testing, and verifying use of critical components. Coordinate factory inspections by NRTL inspectors.

o Support QA Engineers and Product development teams in assuring compliance with standards and directives as applicable which may include RoHS, WEEE, Software Development EN 62304, and Wireless Communications standards.

 Quality System certification

o Represent the organization during third-party Quality Management System audits.

o Respond to audit findings and implement corrective actions.

 Internal Audits

o Assist in the planning and coordination of internal audits. Perform audits of quality system processes.

 Product Development

o Participate on product development teams to assure that regulatory needs are being met.

o Provide input to and review/approve requirements specifications, verification test plans, validation test plans, product transfer/release documentation.

QA/Regulatory Engineer

Product Regulatory compliance

Lead teams in the preparation of documents and records necessary for regulatory compliance (FDA, CE, EU MDR, Health Canada) including risk analysis, MDR general safety and performance requirements, MDR classification, Device Master Records, Technical File, Declaration of Conformity, Clinical Evaluation, etc.

Manage/support organizational and product registrations and listings including FDA Device Establishment Registration, FDA product listings, Health Canada Device Licensing, EU MDR product lists.

Prepare FDA 510K pre-market clearance applications for new or revised products.

Support international partners with the registration of medical devices.

Interact with Notified Body during evaluations of Technical Files.

Prepare and submit vigilance reports for mandatory reporting incidents.

Product Safety and Testing

Oversee third party product testing to applicable device standards (IEC 60601 series).

Maintain North American NRTL safety mark by assuring appropriate production testing, and verifying use of critical components. Coordinate factory inspections by NRTL inspectors.

Support QA Engineers and Product development teams in assuring compliance with standards and directives as applicable which may include RoHS, WEEE, Software Development EN 62304, and Wireless Communications standards.



Job Requirements:
Quality System certification

Represent the organization during third-party Quality Management System audits.

Respond to audit findings and implement corrective actions.

Internal Audits

Assist in the planning and coordination of internal audits. Perform audits of quality system processes.

Product Development

Participate on product development teams to assure that regulatory needs are being met.

Provide input to and review/approve requirements specifications, verification test plans, validation test plans, product transfer/release documentation.













Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required: 5
Education Required:
Overnight Travel: None
Vacation Time: Negotiable / Other


Job Benefits:
Health/Dental Benefits, Retirement Benefits, Paid Holidays, Vacations, and Sick Leave, Casual Dress

Contact Information:
Contact Name: Max Sabrin Company Type: Recruiter
Company: EIR Network Phone: 860-395-5550
Street: Sandy Point Road - Bldg A #2 Fax:
City: Old Saybrook
State: Connecticut
Zip: 06475
Web Site: https://eirnetwork.com

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