Regulatory Affairs Specialist

The Regulatory Affairs Specialist will provide support to the Regulatory Affairs department and across the organization. This position has primary responsibility for assembling regulatory documents for review by the regulatory affairs management.

Essential Job Functions

• Understand, support and follow the Corporate Vision, Mission & Values Statements.
• Support company goals and objectives.
• Understand, follow and support Mizuho OSI’s internal Quality System policies, procedures and work instructions including but not limited to applicable external regulations (21 Code of Federal Regulations Part 820 Quality System Regulations and applicable International Standards).
• Under the direction of the Manager, Regulatory Affairs compile, prepare, review, and submit regulatory submission documents for the company in the U.S. as well as internationally including but not limited to Device Master files, technical files, annual reports, amendments, supplements, etc.
• Gather and assemble information necessary for submissions in accordance with regulations and relevant guidelines.
• Maintain regulatory database of regulatory information and submissions.
• Review, recommend and present regulatory policies, methods, SOPs, protocols, reports for regulatory compliance and report on findings to assure adherence to FDA and global requirements.
• Assist regulatory management and teams in the implementation and delivery of regulatory documentation.
• Participate in Mizuho OSI regulatory training courses and current trends to stay up to date with relevant laws, regulations and guidelines on medical devices developments.
• Develop rapport within and across the company regarding regulatory matters.
• Maintain and develop timelines for regulatory submissions, and correspondence for company sponsored projects.
• Follow general instructions to complete projects, plan and organize workday to complete time sensitive assignments.
• Under the management direction, maintain the Device Manufacturing licenses as required and mandated by the state and/or other regulatory agencies.
• Assist regulatory management and subject matter experts in the coordination of briefing documents and responses to requests or questions from government authorities or other entities.
  
  

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

Job duties are performed in an office environment utilizing standard office equipment such as a computer, photocopier, and telephone. The noise level in the work environment is usually low to moderate.

MINIMUM QUALIFICATIONS - The qualifications below are the knowledge, skills, and abilities required to do this job.

• Bachelor’s Degree (or equivalent); preferably in technical discipline such engineering, biology, chemistry, etc.
• Minimum four (4) years overall experience as Regulatory Affairs Specialist and two (2) years in Medical Devices.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  
  

Knowledge, Skills And Abilities

• Excellent oral and written communication, interpretive and interpersonal skills, including time management skills.
• Strong attention to detail.
• International Product registration, submission and post market experience is an absolute must for this position as well as knowledge of the regulations/requirements for the following: cybersecurity, wireless and sterile products
• Knowledge of 21 CFR and FDA guidelines (GMPs).
• Ability to work on multiple tasks to meet company requirements.
• Demonstrated ability to coordinate and work effectively with cross-functional teams.
• Excellent Computer Skills – MS Word, Excel, Power Point
• Medical Device experience required.
  
  

Annual Salary: $100k – 120k plus bonus

Location: Union City, CA