Sr. Regulatory Affairs Specialist (Wayne, NJ)

Datascope Corporation • Wayne, NJ

254d • $111,925 - $150,000 • Remote

About The Position

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers. Are you looking for an inspiring career? You just found it.

Requirements

• 5 years of experience with Medical Device Regulatory Affairs.
• Experience with ISO 13485, 21 CFR Part 820 FDA QSR, ISO 14971, IEC 62366-1, IEC 60601 Series, IEC 62304 and ISO/TR 20416 standards.
• Proficiency in preparing regulatory submissions such as 510(k) (U.S.), CE Marking (EU), and PMA (Premarket Approval) submissions.
• Knowledge of the EU MDR 2017/745 regulations for medical devices.
• Ability to create and review technical files, including design dossiers, risk management files and clinical evaluation reports (CER).
• Familiarity with global standards for medical device regulation in markets such as Brazil (ANVISA), Canada (Health Canada), Japan (PMDA), China (NMPA), and others.
• Knowledge of regulatory requirements for device labeling, including user manuals, packaging, and instructions for use (IFU) according to local regulations.
• Ability to conduct and manage internal and external audits and inspections, and experience with FDA inspections, ISO audits, and Notified Body assessments.
• Ability to manage regulatory projects, timelines, and cross-functional teams to ensure timely submission and approval of medical devices.
• Familiarity with regulatory affairs and submission management tools, regulatory submission tracking, and compliance management.

Responsibilities

• Responsible for activities which lead to and maintain regulatory approval to market medical devices.
• Assess device and labeling changes for regulatory implications.
• Develop and maintain positive relationships with U.S. FDA, EU Notified Body and global regulatory agencies through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow-up of submissions under review.
• Develop and deliver presentations to global regulatory agencies.

Benefits

• Standard employee benefits apply.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Miscellaneous Manufacturing
• Education Level: Bachelor's degree