Job Information
Astrix Technology Regulatory Affairs Specialist - Software in San Diego, California
Regulatory Affairs Specialist - Software
Regulatory Affairs
San Diego, CA, US
Pay Rate Low: 38 | Pay Rate High: 39
- Added - 21/06/2024
Apply for Job
Our Client specializes in IV therapy, offering a complete range of systems, software, solutions, and consumables to connect patients and caregivers safely and effectively. Their focus is on delivering intuitive, patient-centered IV solutions that enhance clinical outcomes through innovation and superior value. They are currently looking for a Regulatory Affairs Specialist to join their team in San Diego!
Pay: Up to $40/hr
Location: San Diego, CA
Position Summary:
Supports regulatory efforts by developing global strategies, identifying required registration data, ensuring data acquisition, and facilitating product registration. Acts as primary regulatory liaison for assigned projects.
Essential Duties & Responsibilities:
Provides regulatory guidance to assigned products/teams, identifying registration requirements and strategies.
Organizes registration packages in compliance with local regulations.
Liaises with regulatory agencies under supervision.
Assists in preparing meeting materials and strategies for agency interactions.
Assesses regulatory impact of manufacturing, labeling changes, and promotional materials.
Represents Global Regulatory Affairs in R&D meetings, presenting established regulatory positions.
Undertakes special assignments as needed.
Knowledge, Skills & Qualifications:
3-5 years of experience in Regulatory Affairs, R&D, or related fields.
Proficiency in software applications preferred.
Familiarity with 510(k), Q-submissions, and MDR Technical Documentation preferred.
Ability to comprehend scientific arguments.
Strong interpersonal, oral, and written communication skills.
Developing negotiation skills and understanding of business requirements.
Exceptional attention to detail.
Ability to prioritize and adapt to changing priorities.
Self-directed with capacity to multitask in a fast-paced environment.
Education and Experience:
Bachelor's degree required; Master's preferred.
Minimum of 3 years of relevant experience.
Travel Requirements:
- Typically less than 5% travel required.
INDBH
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.