Senior Regulatory Affairs Specialist
Acclarent, a Johnson & Johnson medical device company, is recruiting for a Senior Regulatory Affairs Specialist role to be located in Irvine, CA or remote (in the US). This individual must be able to work on California time zone hours.
With Regulatory Affairs roles at Johnson & Johnson, you can support critical initiatives across the operating company. If you want to work with a diverse team in a fast-paced, challenging and highly collaborative environment passionate about delivering market-leading innovations worldwide while developing strong business leadership skills, we invite you to learn more about the CSS Group and our Johnson & Johnson Family of Companies.
The Cardiovascular & Specialty Solutions (CSS) Group within Johnson & Johnson, consists of four diverse Business Divisions, including: Acclarent (ACC), Biosense Webster Inc (BWI), Mentor (MNT), and CERENOVUS (CNV). Our companies serve a diverse base of customers in Ear, Nose and Throat (ENT), Electrophysiology, Surgical and Non-Surgical Aesthetics, Reprocessing, and Neurovascular.
Our therapies touch the lives of millions of patients every year and our robust and innovative pipeline continues to deliver on the promise of impacting even more patient lives. Join our growing organization that is passionate about providing exciting opportunities for employees to expand their knowledge, skills and experience to help ensure continued career growth and development. Our dedication to developing our leaders is unwavering. Our investment in people, technology, and innovation make us one of the best places to work within one of the most admired corporations in the world.
The Senior Regulatory Affairs Specialist will be developing regulatory submissions and assessments (in compliance with applicable regulations and standards) to ensure timely global commercialization of products.
In this role, you will:
- Develop and implement regulatory strategies and processes to ensure timely global commercialization of products in compliance with applicable regulations and standards.
- Author regulatory submissions and assessments for class II and III medical devices to be distributed in the US to ensure timely global commercialization of products in compliance with applicable regulations and standards.
- Author technical files and design dossiers for products to be distributed in the EU.
- Prepare international documentation to support product registration internationally.
- Directly communicate with FDA and other Regulatory agencies in preparing responses to submissions and in support of agency audits.
- Evaluate proposed changes to product design or manufacturing processes and assess impact of the proposed changes with regard to worldwide approvals and internal BWI policies and procedures.
- Participate on new product development teams
- Review and approve new product development and product modification documentation.
- Write, review and revise company SOPs as required.
- Communicate business related issues or opportunities to next management level.
- Ensure personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
- Communicate with cross functional team members on a regular basis pertaining to product development and launch activities.
- Communicate with Regulatory agencies pertaining to review of product submissions and company-wide audits.
- Perform other duties assigned as needed.
· A minimum of a bachelors degree with at least 4 years of experience in Regulatory Affairs or other related discipline in the medical device of pharmaceutical industries OR an Advanced degree with at least 2 years of experience in Regulatory Affairs or other related discipline in the medical device or pharmaceutical industries
- Practical experience in an FDA Regulated Environment to maintain legal status of products and minimize risk
- General knowledge of US and/or European regulatory processes
- Experience working with sections of regulatory submissions
- Experience working as a member of a team in a timeline-driven environment with limited supervision
- Excellent communication skills (verbal and written)
- Familiarity with electronic submission preparation a plus
- Knowledge of Ear, Nose, Throat (ENT) medical device
- Project management skills
- Problem solving skills
- Presentation skills
- RAC Certification
· This role is to be located Irvine, CA or remote (in the US) for the right candidate. Must be able to work on California time zone hours. This role may require up to 10% travel, domestic or internationally.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .