Job Description

Position: Regulatory Affairs Specialist - $100k - $120k

Fremont, CA

No C2C

My client, an innovative company that specializes in developing specialty surgical solutions. They’ve collaborated with healthcare professionals to address inefficiencies in the operating room, creating products that enhance precision, reduce risk, and improve patient outcomes.

The Regulatory Affairs Specialist provides support to the Regulatory Affairs department, assisting with the preparation and submission of regulatory documentation. This role ensures compliance with U.S. and international regulations while supporting the company’s goals.

Key Responsibilities:

• International Product Registration, Submission and Post Market Experience is a must.
• Contribute to company objectives and adherence to internal Quality System policies and external regulations (e.g., 21 CFR Part 820).
• Assist in compiling and submitting regulatory documents, including Device Master Files, technical files, annual reports, and amendments, under the direction of the Regulatory Affairs Manager.
• Gather and organize information for submissions in line with regulatory requirements and guidelines.
• Maintain and update the regulatory database for submissions and compliance tracking.
• Review and suggest improvements for regulatory policies, SOPs, and reports, ensuring FDA and global compliance.
• Collaborate with regulatory management to deliver necessary documentation and responses to government inquiries.
• Stay current on relevant medical device regulations, laws, and industry trends.
• Build relationships across the company to address regulatory matters effectively.
• Maintain regulatory timelines and assist with company-sponsored project submissions.
• Assist in maintaining required Device Manufacturing licenses per state and regulatory mandates.
• Help coordinate briefing documents and responses for regulatory agencies.

Qualifications:

• Bachelor’s degree (preferred in engineering, biology, chemistry, or related technical field).
• Minimum of 4 years of experience in Regulatory Affairs, with at least 2 years in the medical device industry.
• Knowledge of international product registration, FDA guidelines (GMPs), and medical device regulations.
• Strong attention to detail and ability to manage multiple tasks.
• Excellent communication, teamwork, and time management skills.
• Proficiency in MS Office (Word, Excel, PowerPoint).
• Cybersecurity, wireless technologies, and sterilization knowledge.

Job Tags

Similar Jobs