Senior Regulatory Affairs Specialist ( Medical Devices) Saivance Alameda, CA Job Details Contract $50 - $55 an hour 20 hours ago Benefits Health insurance Dental insurance 401(k) Vision insurance Qualifications FDA submissions Written communication Spreadsheets Regulatory legal research Collaboration with product development teams Analysis skills Product development Regulatory affairs Regulatory submission editing and review Biomedical regulatory compliance Risk & issue management Compliance Cross-functional communication Full Job Description About the Role We are seeking an experienced Senior Regulatory Affairs Specialist to support regulatory activities for medical device products. This position is ideal for a regulatory professional with strong experience in medical device regulatory affairs, U.S. submissions, and regulatory change assessments . The successful candidate will work closely with cross-functional teams and provide regulatory guidance throughout product development, changes, and commercialization activities. Key Responsibilities Support regulatory strategies for new and existing medical device products. Perform regulatory assessments for product and manufacturing changes. Support U.S. medical device submissions and regulatory documentation. Provide regulatory guidance to development and marketing teams. Evaluate regulatory requirements and applicable regulations. Support technical labeling and line-extension activities. Participate in product planning and implementation. Contribute to risk management and regulatory policy activities. Support continuous improvement initiatives within Regulatory Affairs. Serve as a regulatory representative on cross-functional teams. Help ensure timely regulatory approval of new products and continued compliance of marketed products. Communicate regulatory requirements and recommendations to internal stakeholders. Required Qualifications 7+ years of experience in Medical Device Regulatory Affairs. Strong experience with regulatory change assessments . Working knowledge of U.S. medical device regulatory submissions . Experience working with cross-functional product development teams. Strong understanding of medical device regulations and regulatory requirements. Excellent written and verbal communication skills. Strong analytical and problem-solving abilities. Ability to manage multiple priorities and meet deadlines. Preferred Experience Experience with one or more of the following is highly desirable: Regulatory strategy FDA medical device submissions Regulatory change assessments Product development Manufacturing changes Technical labeling Line extensions Risk management Regulatory intelligence Regulatory policy Continuous improvement

Pay:

$50.00 - $55.00 per hour

Benefits:

401(k) Dental insurance Health insurance Vision insurance

Experience:

Medical Device:

7 years (Required)

Work Location:

In person