Find & Apply For Regulatory Affairs Specialist Jobs in Alameda, California

Job Title:

Medical Device Regulatory Affairs Specialist Location:

Alameda, CA Employment Type:

Contract Duration:

Longterm Salary /

Rate:

$45-$50/hr on W2

Job Summary:

We are seeking an experienced Medical Device Regulatory Affairs Specialist with 7+ years of experience in medical device regulatory affairs, strong expertise in regulatory change assessments, and working knowledge of U.S. medical device submissions. The ideal candidate will support regulatory strategies, facilitate timely approvals for new medical devices, maintain regulatory approvals for marketed products, and collaborate with cross-functional teams to ensure compliance with applicable regulatory requirements.

Responsibilities:

Perform regulatory change assessments and evaluate their impact on medical devices and regulatory compliance. Apply working knowledge of U.S. medical device submissions and applicable regulatory requirements. Participate in continuous improvement initiatives, product plan development and implementation, regulatory strategy, risk management, regulatory policy, and regulatory intelligence activities. Support timely regulatory approval of new medical devices and maintain approvals for marketed products. Serve as the Regulatory Affairs representative on cross-functional teams and provide regulatory guidance. Advise product development and marketing teams on manufacturing changes, product line extensions, technical labeling, and applicable regulations and interpretations. Assess regulatory implications of product and manufacturing changes and provide appropriate recommendations. Collaborate with relevant stakeholders to support regulatory compliance throughout the product lifecycle.

Required Qualifications:

Minimum of 7 years of experience in Medical Device Regulatory Affairs. Demonstrated experience conducting regulatory change assessments. Working knowledge of U.S. medical device submissions. Understanding of regulatory requirements related to medical device development, manufacturing changes, labeling, and marketed products. Experience collaborating with cross-functional teams and providing regulatory guidance.

Work Requirements:

Work Schedule:

Monday-Friday, 9:00 AM-5:00 PM.

Work Arrangement:

Onsite. Benefits Employees hired into this position are eligible for the following benefits, subject to the applicable plan terms and eligibility requirements:

Health Insurance:

Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.

Retirement Benefits:

A 401(k)-retirement savings plan is available. No employer matching or other employer contributions are provided. Paid Time Off (PTO): No PTO other than that required by applicable state and local laws

Equal Employment Opportunity :

Intellectt Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law.

Application:

Interested candidates with relevant medical device regulatory affairs experience are encouraged to apply with an updated resume.

Pay:

$45.00 - $50.00 per hour Expected hours: 40.0 per week

Benefits:

401(k) Retirement plan

Work Location:

In person