What are the responsibilities and job description for the Senior Regulatory Affairs Specialist position at Medasource?
Job Details
Job Description
Location: Onsite Irvine, CA
Contract: 1-Year Contract with potential for extension
Company: J&J Vision
About the Opportunity
We re supporting Johnson & Johnson Vision in hiring a Senior Regulatory Affairs Specialist for a one-year contract role with strong potential to extend. This is a great opportunity to join a growing team at one of the most respected and innovative surgical vision companies in the world. The position is fully onsite in Irvine, CA, working closely with global regulatory teams on high-visibility international submissions.
Role Overview
The Senior RA Specialist will support global regulatory submissions and documentation across multiple regions, including Latin America, APAC, Europe, the Middle East, and Africa. This role is ideal for someone who thrives in a structured, fast-moving regulatory environment and enjoys hands-on documentation and submission work.
Key Responsibilities
- Prepare, manage, and finalize technical documentation for international regulatory submissions, including new product registrations, renewals, and change submissions.
- Gather data, respond to regulatory agency requests, and ensure all documentation complies with internal standards and global regulatory guidelines.
- Publish, archive, and maintain regulatory documents within electronic documentation and quality management systems.
- Support labeling creation, formatting, and preparation using company publishing tools.
- Coordinate with global and regional RA teams to streamline processes and improve submission efficiency.
- Track and report submission metrics; maintain consistency across documentation templates and formats.
- Assist with notarization, legalization, or apostille of documents for international Health Authorities.
- Stay current on regulatory changes and assess the impact of new standards, guidance, or regulations.
- Work independently with minimal supervision while collaborating closely with global partners.
What Makes This a Great Opportunity
- Join J&J Vision, a global leader in surgical vision technologies and innovation.
- Work onsite with a highly collaborative, rapidly growing team involved in meaningful global regulatory work.
- Gain exposure to international submissions and regulatory processes across multiple markets.
- Strong potential for extension beyond the initial one-year contract.
Ideal Background
- Experience in Regulatory Affairs within medical devices, pharma, or related health-regulated industries.
- Strong skills in technical documentation, regulatory submissions, and electronic document management systems.
- Ability to manage multiple priorities, work independently, and maintain high-quality documentation.