Regulatory Affairs Manager III

eTeam; New Jersey; On-site; USD 80,000 - 100,000; Full time

Job summary

eTeam is seeking a qualified candidate to manage regulatory documentation and support international registrations for medical devices in New Jersey. The ideal candidate will exhibit competence in US and foreign regulations, possess strong project management skills, and handle proprietary information confidentially.

Applicants should have a bachelor’s degree in science or biomedical engineering, with 4–6 years of relevant experience in regulatory activities. An advanced degree and RAC Certification are desirable, with evidence of foreign regulatory approvals being a plus.

Qualifications

• Bachelor degree from accredited college or university in science or related field.
• 4–6 years of experience in regulatory activities for medical devices.
• Experience with foreign regulatory approval/clearance.

Responsibilities

• Prepare and file regulatory documentation for medical devices.
• Assist in the preparation of international registrations and amendments.
• Manage proprietary information with confidentiality.

Skills

Project management

Oral communication

Problem-solving

Decision making

Education

Bachelor degree in science or biomedical engineering

Advanced degree

RAC Certification

Job description

Job Description

• Exhibit competence in US & foreign government regulations regarding the manufacture & distribution of medical devices
• Assist with activities necessary for the timely preparation, writing & submitting of international registrations (technical files), & all related amendments & supplements. EU experience with dossiers and technical files a plus
• Exhibit competence in preparing, writing & filing regulatory documentation
• Manage a significant amount of proprietary information in an extremely confidential manner
• Possess strong project management skills
• Possess good oral communication skills – presentation & meeting interactions
• Work as a self-starter – work effectively with some supervision
• Possess strong problem‑solving & priority setting
• Exhibit strong decision making – numerous independent decisions every day & must therefore have the ability & confidence to effect informed decisions based upon regulatory expertise, government constraints, & a thorough understanding of business needs

Qualifications

• Education requirements: Bachelor degree from accredited college or university in science, biomedical engineering, medical/scientific writing, public health administration
• Advanced degree is desirable
• RAC (Regulatory Affairs Certification) by Regulatory Affairs Professional Society, desirable
• Evidence of foreign regulatory approval/clearance of new or modified medical devices; experience with higher risk device desirable
• 4–6 years of successful experience conducting regulatory activities that achieved domestic & foreign regulatory