Acara Solutions is looking for a Sr. Regulatory Affairs Specialist with medical device experience in Brea, CA. This position is a contract position lasting 6-8 months.
Pay: $45 hourly
This person needs to be a Regulatory Lead on New Product Development cross-functional teams (i.e. helping new products and/or changes to existing products launch into market having met all compliance and design control requirements).
Position Overview:
The Sr. Regulatory Affairs Specialist creates, evaluates, and completes regulatory tasks related to the following: worldwide product registration submissions, facility registrations, technical files, FDA submissions, special projects, and strategy to drive market growth worldwide. This individual is responsible for obtaining global regulatory clearances/approvals based on company objectives, attending product development meetings, regional alignment; as well as collaborating with cross-functional departments to ensure country-specific requirements are met and integrated throughout the design control and post-product launch activities. This position will be based at our HQ in Brea, CA and will require someone work on-site 3x per week.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Job Requirements
JOB REQUIREMENTS:
SKILLS & QUALIFICATIONS:
Aleron companies (Acara Solutions, Aleron Shared Resources, Broadleaf Results, Lume Strategies, TalentRise, Viaduct) are Equal Employment Opportunity and Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender identity, sexual orientation, national origin, genetic information, sex, age, disability, veteran status, or any other legally protected basis. The Aleron companies welcome and encourage applications from diverse candidates, including people with disabilities. Accommodations are available upon request for applicants taking part in all aspects of the selection process.
Applicants for this position must be legally authorized to work in the United States. This position does not meet the employment requirements for individuals with F-1 OPT STEM work authorization status.
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