Regulatory Affairs Manager job New York New York
Regulatory Affairs Manager job New York New York
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Regulatory Affairs Manager Job



Employer Name: EIR Network SpiderID: 8878640
Location: New York, New York Date Posted: 8/19/2019
Wage: Category: Manufacturing
Job Code:
Number Of Openings: 1

Job Description:
Regulatory Affairs Manager

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
Support QA Engineers and Product development teams in assuring compliance with standards and directives as applicable which may include IEC 60601 series, EN 14971 (Risk Management), EN 62366 (Useability) RoHS, WEEE, EN 62304 (Software Development), and Wireless Communications standards.
Maintain North American NRTL safety mark by assuring appropriate production testing, and verifying use of critical components. Coordinate factory inspections by NRTL inspectors.
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 defined, that compliance activities are appropriate, and that evidence of compliance is documented.
Provide input to and review/approve: requirements specifications; verification test plans; validation test plans; product transfer/release documentation.




Job Requirements:
Qualifications:

Bachelor’s degree, preferably in a technical/engineering discipline.
Five years’ experience in product regulatory compliance within a design, development and manufacturing environment.


Skills and Knowledge:

Strong technical writing skills a MUST. Ability to develop and document procedures.
Effective interpersonal and communication skills.
Ability to effectively manage projects, including interactions with other organizational functions.
Knowledge of medical device quality system standard ISO 13485, U.S. FDA Quality System Regulation, European Union Medical Devices Regulation, Health Canada Medical Devices Regulation.
Experience and proficiency with internal QMS auditing.


EIR Network is an Equal Opportunity/ Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, disability, or protected Veteran status.



Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required: 5
Education Required: Bachelors
Overnight Travel: None
Vacation Time: 2 weeks / year


Job Benefits:
Health/Dental Benefits, Retirement Benefits, Paid Holidays, Vacations, and Sick Leave, Life and/or Disability Insurance, Casual Dress, Other Benefits

Contact Information:
Contact Name: Max Sabrin Company Type: Recruiter
Company: EIR Newtowk
City: Old Saybrook
State: Connecticut
Zip: 06475
Web Site: https://eirnetwork.com

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