Regulatory Affairs Specialist

Date:  Sep 20, 2022
Category:  Regulatory Affairs Quality Assurance
Location: 

Union City, CA, US

Over 40 years of innovation and development, Mizuho OSI is a world-leading manufacturer of highly specialized surgical tables for spine and hip surgeries. We do things the right way. We commit to hire people with competence, generosity and a caring attitude. We motivate our employees to use their individual strengths to provide creative solutions, changes, and innovations. Collectively, this creates an environment that enables and inspires healthcare professionals to improve the lives of patients.

Dare to go further. Care to do more.

 

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 values of R.E.S.P.E.C.T. and the Mizuho way.

  • Create innovative solutions designed and manufactured at our HQ in Northern California

 

SCOPE:

 

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:

  1. Understand, support and follow the Corporate Vision, Mission & Values Statements.

  2. Support company goals and objectives.

  3. 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).

  4. 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.

  5. Gather and assemble information necessary for submissions in accordance with regulations and relevant guidelines.

  6. Maintain regulatory database of regulatory information and submissions.

  7. 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.  

  8. Assist regulatory management and teams in the implementation and delivery of regulatory documentation.

  9. 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.

  10. Develop rapport within and across the company regarding regulatory matters. 

  11. Maintain and develop timelines for regulatory submissions, and correspondence for company sponsored projects.

  12. Follow general instructions to complete projects, plan and organize workday to complete time sensitive assignments.

  13. Under the management direction, maintain the Device Manufacturing licenses as required and mandated by the state and/or other regulatory agencies.

  14.  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.

 

PHYSICAL REQUIREMENTS

The physical demands described here are representative of those that must be met by an employee to successfully perform essential functions of the job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Duties are performed while sitting at a desk for long periods of time. Required duties include operating a computer, reading, writing and using a telephone. Walking or standing within the office area may be required for the operation of office equipment and for attending meetings.

 

MINIMUM QUALIFICATIONS - The qualifications below are the knowledge, skills, and abilities required to do this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

KNOWLEDGE, SKILLS AND ABILITIES:

  1. Excellent oral and written communication, interpretive and interpersonal skills, including time management skills.

  2. Strong attention to detail.

  3. Knowledge of 21 CFR and FDA guidelines (GMPs).

  4. Ability to work on multiple tasks to meet company requirements.

  5. Demonstrated ability to coordinate and work effectively with cross-functional teams.

  6. Excellent Computer Skills – MS Word, Excel, Power Point  

  7. Medical Device experience required.

 

 

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

The Mizuho OSI Way

In 1978, we set out to change the way patients undergo surgery. As a Mizuho OSI customer, you can expect our commitment to the following…
• We commit to your satisfaction. If you are dissatisfied, we will strive to make it right.
• We do things the right way. We commit to hire people with competence, generosity and a caring attitude.
• We motivate our employees to use their individual strengths to provide creative solutions, changes, and innovations.
• We anticipate your needs through customer experiences, thus nurturing our relationships.

Collectively, this creates an environment that enables and inspires healthcare professionals to improve the lives of patients.
Dare to go further. Care to do more.

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.

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. If you are a Veteran or wounded warrior and would like assistance with the employment process at Mizuho OSI, please contact HR at (510) 429-1500.

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. If you need additional assistance, information or answers to your questions, feel free to contact HR at (510) 429-1500.


Nearest Major Market: San Francisco
Nearest Secondary Market: Oakland