Johnson & Johnson Careers

Manager, Regulatory Affairs

Santa Ana, California
Submissions


Job Description

Requisition ID: 7936190220

Johnson & Johnson Surgical Vision (JJSV) is recruiting for a Manager, Regulatory Affairs in Santa Ana, CA. JJSV designs, manufactures, and distributes products for the surgical treatment of anterior segment ophthalmic disorders, including cataract removal and ocular surface disease.

 

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.

 

The Johnson & Johnson Surgical Vision goal is improving sight throughout a patient’s lifetime. J&J Surgical Vision is well positioned to address a full range of vision health needs for global markets: The No. 2 global provider of CATARACT products and a leader in presbyopia-correcting IOLs, the Global REFRACTIVE (LASIK) market leader, all supported with a CONSUMER EYE HEALTH diverse portfolio of solutions and drops ensuring ocular surface health.

 

Johnson & Johnson Surgical Vision has operations in the United States, Latin America, Asia-Pacific and Europe/Middle East/Africa regions. Research, innovation and new-product development are the focus of our organization. Our associates around the world are committed to expanding our brands and fortifying our position as the worldwide leader in the industry.

 

The Manager, Regulatory Affairs will be responsible for administering day-to-day Regulatory Affairs department activities by directly or indirectly managing teams of employees or managing third-party vendors.  The Manager combines knowledge of scientific, regulatory and business issues to enable JJSV products to meet required legislation, will have department/site level influence and be generally recognized as an expert resource within the department. The role encompasses identifying emerging regulatory issues, analyzing broad scope implications of changing regulations and guidance to provide direction to product development teams. The Manager will identify data needed, work with cross functional partners to 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.   This position will have direct supervisory responsibilities.

 
In this role, you will:
  • Provide tactical and strategic regulatory leadership to the organization and manage one or more regulatory programs, including continuous improvement activities, compliance related projects and/or new product development.   
  • Lead projects, develops sound regulatory strategies for long-term registrations of new or modified products (e.g., 510(k)s, technical files, dossiers) for domestic and foreign submissions and registrations. 
  • Lead in the understanding and awareness of the US, Canada, EU and other international regulatory requirements to ensure compliance. 
  • Review and approve post-market changes, device labeling and marketing materials for compliance with applicable regulations
  • Interpret 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 make decisions regarding work processes or operational plans and schedules.  Solve 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. 
  • Provide day-to-day instructions and suggested training activities to direct reports, as applicable; assign projects or activities to individual contributors.
  • Represent regulatory affairs in cross-functional project teams and plans schedules for regulatory deliverables on a project and monitors project through completion.
  • Prepare 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.

Qualifications
  • A minimum of a Bachelors degree in an Engineering or Science field is required. Advanced degree is preferred.
  • A minimum of 8 years of regulatory related experience in a regulated industry with a Bachelor’s degree is required, or Masters/PharmD and 6 years, or PhD and 4 years’ experience.
  • Experience with software-driven electromechanical medical devices is preferred.
  • Strong communication, organizational, negotiation and interpersonal skills is preferred
  • Expert knowledge, understanding and application of principles concepts and practices of government regulations and applicable standards (e.g. IEC 60601-1 and ISO 14971) is preferred
  • Ability to organize and analyze technical data and identify issues or gaps is preferred
  • Demonstrated skills in area of staff support and development (directly or indirectly) is preferred
  • Foundational regulatory knowledge to maintain legal status of products and minimize risk 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. 
  • Self-motivated and committed to a team approach.    
  • Ability to travel; may require up to 20% domestically and/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. 



Primary Location
United States-California-Santa Ana-
Organization
AMO Development, LLC (6242)
Job Function
Submissions
Requisition ID
7936190220