Senior Specialist, International RA

The Senior Regulatory Affairs Specialist, International Registrations provides direct Worldwide Regulatory support to various projects and products. This position supports strategic planning and international regulatory efforts. 

In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position: 

• Under moderate supervision, identifies and prepares detailed international registration documentation that supports all stages of a medical device's lifecycle, from initial product registration through end-of-life, ensuring that all documentation needs for international JNJ affiliates are met effectively. 

• Implements methods for planning, directing, coordinating, and controlling the submission of international Regulatory documents to Regulatory agencies, including but not limited to responses to global Health Authority inquiries. 

• Develops and sustains relationships with RA affiliates as their primary point of contact, contributing to the development and execution of local registration strategy. 

• Applies in-depth knowledge to cross-functional project teams on international RA issues in the development of registration plans to ensure timely commercialization of new and modified products into international markets. 

• Communicates the interpretation of new and changing government regulations to ensure compliance with regulatory/government standards. 

• Maintains Regulatory Affairs databases and communications tools, including SharePoint site, 

• Regulatory databases, request tracking systems, and electronic libraries. 

• Writes, reviews and revises company SOPs as required. 

• Collaborates with internal and external stakeholders to obtain necessary documentation required for international regulatory activities. 

• Performs global planning to ensure visibility, alignment, and optimal resource allocation. 

• Communicates business related issues or opportunities to next management level. 

• Follows all Company guidelines related to Health, Safety and Environmental practices as applicable. 

• Ensures personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures. 

• Performs other duties assigned, as needed. 

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.   

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.