RA Specialist 3

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Category: Regulatory Affairs Quality Assurance

Location: Union City, CA, US, 94587

MIZUHO ORTHOPEDIC SYSTEMS, INC.

Job Title: REGULATORY AFFAIRS SPECIALIST 3

Job Location: 30031 Ahern Avenue, Union City, CA 94587

Job Duties: Mizuho Orthopedic Systems, Inc. in Union City, CA is seeking a 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 Mizuho 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. International Regulatory Requirements
3. FDA compliance in the medical device industry
4. Regulatory training with relevant laws, regulations, and guidelines on medical device development.

No Travel. Work from home benefits allowed.

Additional Information:

• Must be legally authorized to work in the United States without sponsorship.

EOE STATEMENT
Mizuho OSI is an Equal Opportunity Employer and makes business decisions based on job related criteria only. Company policy prohibits unlawful discrimination based on race, color, religious creed, gender, religion, marital status, registered domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition including genetic characteristics, sexual orientation, sexual identity, or any other consideration made unlawful by federal, state or local laws.

Mizuho OSI conducts criminal conviction background checks and drug screening through a third-party screening vendor which includes searches of address history, criminal convictions, court records, education verification, employment verification, and reference checks.

Top Reasons To Join The Mizuho OSI Team:
• Privately held company with a tradition of market leadership and best-in-class innovation
• Fast-paced entrepreneurial culture focused on dramatically improving patient outcomes through personal empowerment
• Emphasis on continuous improvement and celebration of our values of R.E.S.P.E.C.T. and the Mizuho OSI Way.
• Create innovative solutions designed and manufactured at our HQ in Northern California

BENEFITS
At Mizuho OSI, we believe better solutions and decisions are born of diversity and are proudly an EEO/AA employer. We offer a comprehensive benefits package that includes: medical, dental, vision, life insurance, 401k with matching, educational assistance and more.

FOR OUR SERVICE MEMBERS AND VETERANS
Mizuho OSI values the service Veterans and their family members have given to our country and we support the hiring of returning Service Members and military spouses.

FOR PERSONS WITH DISABILITIES
If you are a person with a disability or a disabled Veteran and are applying for a job with Mizuho OSI, we would like to ensure your application process goes as smoothly as possible.