Senior Regulatory Affairs Specialist, Program Lead

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:
Regulatory Affairs Group

Job Sub Function:
Regulatory Product Submissions and Registration

Job Category:
Professional

All Job Posting Locations:
Santa Clara, California, United States of America

Job Description:

Employer:       Auris Health, Inc.

Job Title:         Senior Regulatory Affairs Specialist, Program Lead

Job Code:        A011.485

Job Location:  New Brunswick, NJ

Job Type:        Full-Time

Rate of Pay:     $135,000 - $160,000

Job Duties: Author regulatory submissions and support product development stages to help the organization achieve US and international regulatory (NPD) approval goals.

Support health authority communications and contribute to strategy development.

Manage, prepare, and submit regulatory submissions required for device approvals and registrations in the US and globally.

Oversee SME resources preparation of submission deliverables to meet regulatory requirements or other project objectives.

Correspond and collaborate with international J&J colleagues on international approval efforts.

Conduct regulatory evaluation of changes to Auris devices in accordance with requirements of commercial/operating geography and generate the required regulatory submission.

Anticipate program risk and make recommendations for mitigations.

Function as a Regulatory Affairs subject matter expert on new product introduction and lifecycle management supporting cross functional partners including clinical, marketing, and engineering through design control activities.

Conduct reviews and provide expert regulatory feedback on specifications, device testing, risk management, and other relevant documentation in accordance with regulatory requirements and positioning for regulatory submission.

Assist research personnel, application specialists, and risk management specialists to ensure clinical research and clinical evaluations are performed in accordance with regulatory requirements.

Support quality system and technical file/design dossier audits.

Translate and simplify problems of considerable scope and complexity into manageable tasks with measurable requirements.

May telecommute.

Requirements: Employer will accept a Master's degree in Pharmacy Administration, Biomechanical Engineering, or related field and 4 years of experience in the job offered or in a Senior Regulatory Affairs Specialist, Program Lead-related occupation.

This job posting is anticipated t...