Johnson & Johnson Surgical Vision , part of the Johnson & Johnson MedTech portfolio, is currently hiring for a Manager, Regulatory Affairs to support our product portfolio. This role will work a Flex/Hybrid schedule and can be located within a commutable distance of Irvine, CA or Milpitas, CA . At Johnson & Johnson Surgical 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.
The Manager Regulatory Affairs has the responsibility and authority to manage programs and projects in support of the regulatory demands of the JJSV business specifically related to medical device software. This role will administer day-to-day Regulatory Affairs department activities by directly and indirectly managing teams of employees or managing third-party vendors. Combines knowledge of scientific, regulatory and business issues to enable JJV products to meet required legislation. They will have department/site level influence and be generally recognized as an expert resource within the department. This individual will be able to identify emerging regulatory issues and analyze broad scope implications of changing regulations and guidance. Identify data needed, obtain these data and ensure that they are effectively presented for the registration of products worldwide. Utilize technical regulatory skills to propose strategies on complex issues.
Primary Responsibilities :
· Provides tactical and strategic regulatory leadership to the organization and manages one or more regulatory programs, including continuous improvement activities, compliance related projects and/or new product development.
· Leads projects, develops sound regulatory strategies for long-term registrations of new or modified products (e.g., PMAs, 510(k)s, technical files, dossiers) for domestic and foreign submissions and registrations.
· Leads in the understanding and awareness of the US, EU, Canadian and other international regulatory requirements to ensure compliance.
· Reviews and approves post-market changes, device labeling and marketing materials for compliance with applicable regulations.
· Interprets regulatory requirements and oversees aspects of submission of licenses and authorizations for the maintenance of existing products, international registrations and dossiers including assessment of the impact product changes have on the status of regulatory licenses.
· Independently makes decisions regarding work processes or operational plans and schedules. Solves issues through information exchange, influence and active persuasion with or without direct authority to gain cooperation of other functions on program initiatives such as business development, life cycle management initiatives and/or new product development.
· Provides day-to-day instructions and suggested training activities to direct reports, as applicable; assigns projects or activities to individual contributors.
· Represents regulatory affairs in cross-functional project teams and plans schedules for regulatory deliverables on a project and monitors project through completion.
· Prepares the responses to regulatory agency inquiries and other correspondence (either directly or indirectly through supervision of others)
· Formulates policies for department/area of responsibility and responsible for recruiting professionals (as needed)
· Ensures organization compliance with all applicable regulations and J&J policies. Assists with audits and inspections, as required.
The base pay range for this position in Irvine, CA is $115,000 to $175,000 based on experience . The base pay range for this position in Milpitas, CA is $140,000 to $200,000, again based on experience .
Education & Experience Requirements :
· Minimum of a Bachelors’ Degree is required ; Advanced degree strongly preferred .
· Minimum 8+ years’ experience in Regulatory Affairs within the Ophthalmology, Medical Device, and/or Pharma sector. Software as a device experience and knowledge of Artificial Intelligence (AI) in medical devices is a plus .
· At least 2+ years direct people management experience with demonstrated people development.
· Foundational regulatory knowledge to maintain legal status of products and minimize risk required .
· Expert knowledge, understanding and application of principles concepts and practices of government regulations ( FDA, EU MDR, Health Canada, ISO, ANSI, etc ).
· Strong communication, organizational, negotiation and interpersonal skills.
· Ability to organize and analyze technical data and identify issues or gaps.
· Demonstrated skills in area of staff support and development (directly or indirectly).
· Broad based technical knowledge and skills in diverse areas of business (e.g. R&D, Operations, QA, laboratories, marketing, etc.) and ability to effectively negotiate and influence upper management, affiliates, and Regulatory agencies are a plus.
· Self-motivated and committed to a team approach.
· Ability to travel up to 10% as needed.
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.