Regulatory Specialist

Regulatory Specialist

Department: Regulatory Affairs

Location - Remote
This is a fully remote position.

Role Type: Contract
This is a multi-year contract role with the possibility of conversion to a full-time position.

About Our Client
Our client is a leading medical device and pharmaceutical company dedicated to improving lives through innovative products and solutions. With a rich history spanning decades, they operate globally and are renowned for their commitment to quality, safety, and advancing healthcare. Their core values center around integrity, collaboration, and putting patients first.

Job Description
In this crucial role, you will be responsible for ensuring our organization maintains full compliance with regulatory requirements for medical devices and drug filings. Your expertise will guide the annual FDA report filing process, 501(k) submissions, and other critical regulatory activities. You will serve as the subject matter expert on Japanese and Chinese regulations, keeping the organization updated on changes that may impact our products and processes.

On a daily basis, you will be deeply involved in biocompatibility assessments, change management for products, and risk management activities. Cross-functional collaboration will be key as you work closely with internal teams and external stakeholders to interpret regulations, develop strategies, and ensure adherence to policies and procedures.

Duties and Responsibilities

• Prepare and submit annual FDA reports and 510(k) submissions
• Maintain comprehensive knowledge of regulations pertaining to medical devices and drugs
• Analyze impacts of new and updated regulations on products and operations
• Advise cross-functional teams on regulatory compliance requirements
• Manage regulatory data files and documentation
• Report on compliance status to internal and external parties
• Support biocompatibility evaluations, change control, and product risk management activities
• Draft standard customer letters and communications related to regulatory matters

Required Experience/Skills

• 3-5 years of experience in Regulatory Affairs for the medical device industry
• Proven experience with regulatory device and drug master file submissions
• Medical Device Industry
• Strong understanding of regulatory compliance requirements
• Excellent written and verbal communication skills
• Ability to convey complex regulatory information clearly to stakeholders
• Proficiency with regulatory submission processes and tools
• Bachelor's degree in a relevant field (Biology, Engineering, Regulatory Affairs, etc.)

Nice-to-Haves

• Medical device/drug regulations
• Familiarity with quality management systems and ISO standards
• Project management skills and experience leading cross-functional initiatives
• Fluency in Japanese and/or Mandarin Chinese

Pay & Benefits Summary

• Hourly rate of up to $50/hour for the duration of the contract
• Potential for conversion to a full-time role with a competitive base salary and benefits package

Apply Now and join our client's mission of delivering life-changing solutions to patients worldwide

Keywords: Regulatory Affairs | Medical Devices | Drugs | Japan Regulations | China Regulations | 501(k) Submissions | FDA Reports | Regulatory Compliance | Biocompatibility | Risk Management