Senior Regulatory Affairs Associate

Johnson & Johnson Surgical Vision (JJSV) is recruiting for a Senior Regulatory Affairs Associate in Irvine, CA. Remote work options in the United States may be considered on a case-by-case basis and if approved by the Company. At Johnson & Johnson Vision, we have a bold ambition: to change the trajectory of eye health. That’s why, through our operating companies, we’ve developed solutions for every stage of life—to help people see better, connect better and live better. We partner with eye care professionals to provide some of the world’s leading products and technologies to address refractive error, cataracts, dry eye, and beyond. We are committed to using our reach and size for good, and strive to put quality eye care within reach of everyone, everywhere. Visit us at www.jjvision.com. Follow @JNJVision on Twitter and Johnson & Johnson Vision on LinkedIn. The Senior Regulatory Affairs Specialist will provide regulatory support in any number of areas: review/analyze impact of modifications to manufacturing process, product, and packaging to the registration status of approved products and help determine the appropriate regulatory pathway, review/approve advertising & promotional materials, re-registration activities in support of OUS registrations, help develop regulatory strategies for new product development initiatives, and/or regulatory operations activities in archiving/assembling/publishing regulatory filings and other health authority communications. JJSV designs, manufactures, and distributes products for the surgical treatment of anterior segment ophthalmic disorders, most notably cataract removal. In this role, you will: Coordinate and submit licenses (including EU MDR) and authorizations for the maintenance of existing products, international registrations and dossiers, updates to DOC (technical files), engineering and device change requests. Research, collect data, and respond to requests from regulatory agencies to prepare and submit documentation for marketing approvals (US, Canada and EU), as well as to provide routine regulatory information to associates and affiliates. Provide regulatory guidance to product development teams and responds to product information requests. Represent regulatory affairs in cross-functional project teams and plans schedules for regulatory deliverables on a project and monitors project through completion. Prepare regulatory labeling requirements specifications for new and modified products; review product labeling for existing products to ensure compliance. Assist in the development of best practices for Regulatory Affairs processes Provide Regulatory Affairs support during internal and external audits Adhere to environmental policy and procedures and support department environmental objectives. Qualifications Required: A minimum of a Bachelors degree with 4 years of relevant experience (such as RA, QA, R&D, Legal, etc.) OR an Advanced degree with 2 years of experience is required Practical experience in an FDA Regulated Environment to maintain legal status of products and minimize risk is required General knowledge of US and/or European regulatory processes is required Experience working with sections of regulatory submissions is required Experience working as a member of a team in a timeline-driven environment with limited supervision is required Ability to partner and influence key stakeholders is required Excellent written, verbal communication and presentation skills This position will be located in Irvine, CA and may require up to 10% domestic and/or international travel Preferred: Experience in Medical Device is preferred People management skills is preferred A candidate that is process oriented is preferred Knowledge of EU Medical Device Regulation (MDR) is preferred Experience in change management is an asset Knowledge of international regulatory requirements (China, Japan, Australia, etc.) is a plus Ability to organize and analyze technical data and identify issues or gaps is preferred Broad based technical knowledge and skills in diverse areas of business (e.g. R&D, Operations, QA, Marketing, Clinical research etc.) and ability to effectively negotiate and influence upper management, affiliates, and Regulatory agencies are a plus The base pay range for this position is $101,500 - $142,000 The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis. Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below. Eligible for benefits to include medical, dental, vision and time off as well as any others as provided for in the applicable Collective Bargaining Agreement. For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits 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 Primary Location United States-California-Irvine-31 Technology Dr Other Locations North America-United States Organization AMO Development, LLC (6242) Job Function Regulatory Affairs Requisition ID 2206054957W