Mizuho Orthopedic Systems, Inc. in Union City, CA is seeking Regulatory Affairs Specialist 3 to coordinate and document internal regulatory processes, such as internal audits, inspections,
license renewals, or registrations.

Job responsibilities and duties include:
1. Compile, prepare, review, and assemble regulatory documents necessary for submissions in accordance with regulations and relevant guidelines.
2. Gather and assemble information/documentation 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, and assist in delivery of regulatory documentation.
3. Maintain regulatory database/network drive folders with regulatory information and submissions.
4. Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
5. 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.
6. Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
7. Identify relevant guidance documents, international standards, or consensus standards, and provide interpretive assistance.
8. Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
9. Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.
10. Write or update standard operating procedures, work instructions, or policies.
11. Coordinate product recall or market withdrawal activities as necessary.
12. Develop or track quality metrics and participate in internal/external audits.
13. Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
14. 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.
15. Maintain and develop timelines for regulatory submissions, and correspondence for company sponsored projects.
16. Under management direction, maintain the Device Manufacturing licenses as required and mandated by the state and/or other regulatory agencies.
17. Assist regulatory management and subject matter experts in the coordination of briefing documents and response to requests or questions from government authorities or other entities.
18. Understand, follow, and support Mizhuo OSI’s internal quality system policies/procedures and instructions including external regulations (21 Code of Federal Regulations Part 820 Quality System Regulations and applicable international standards).

Minimum requirements: Master's degree in Biological Sciences, Life Sciences, Pharmaceutical Sciences, Bioengineering, or any related field of study, plus one (1) year of experience in the job offered or in any related position(s) in which the experience was gained.
Qualified applicants must also have demonstrable proficiency, skill, experience, and knowledge with the following:

1. Regulations 21 CFR (21 Code of Federal Regulations Part 820 Quality System Regulations)
2. FDA guidelines (GMPs)
3. International Regulatory Requirements
4. Computer skills: MS Word, Excel, PowerPoint
5. FDA compliance in the medical device industry

Require regulatory training with relevant laws, regulations, and guidelines on medical device development.

No Travel. Work from home benefits allowed.


Additional Information:

● Job Site: 30031 Ahern Avenue, Union City, CA 94587
● Salary: $107,542 per year.
● Interested applicants apply at company website.
● No calls or emails. EOE.
● Must be legally authorized to work in the United States without sponsorship.


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