RA Specialist 4

Category: Regulatory Affairs Quality AssuranceLocation: Union City, CA, US, 94587About CompanyMizuho OSI is the leader in the markets for specialty surgery and patient positioning. The company’s portfolio includes specialty surgical tables for procedure-specific approaches that improve patient outcomes in spine and orthopedic surgeries along with disposable and reusable surgical patient care products.Job SummaryThe Regulatory Affairs Specialist has primary responsibility for assembling regulatory documents for review by the regulatory affairs management. This position will provide support to the Regulatory Affairs department and across the organization.Responsibilities:Compile, prepare, review, and assemble regulatory documents necessary for submissions in accordance with regulations and relevant guidelines.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 etc. and assist in delivery of regulatory documentation.Maintain regulatory database/network drive folders with regulatory information and submissions.May communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.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.Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.Write or update standard operating procedures, work instructions, or policies.May coordinate product recall or market withdrawal activities as necessary.Develop or track quality metrics.May participate in internal or external audits.Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.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.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).Qualifications & Requirements:Experience and education – as outlined below, per job level.Working Knowledge of 21 CFR and FDA guidelines (GMPs) and international regulatory requirements.Ability to express oneself orally and in writing in the English language. Ability to communicate effectively with Team Members across the organization and other business contacts in a courteous and professional manner.Excellent interpretive and interpersonal skills, including time management skills.Strong attention to detail.Ability to work on multiple tasks to meet company requirements.Demonstrated ability to coordinate and work effectively with cross-functional teams.Annual Salary: $98k - $120k and 8% MBOThis is a hybrid position.EOE STATEMENTMizuho 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. In addition, depending on the nature of the position for which you are applying, a motor vehicle driving report, a credit report, and/or ID checks in other non-U.S. countries are also included.Criminal conviction background checks will run after an applicant has received and accepted a conditional offer of employment. After a conditional offer is made and before any background check is performed, applicants will receive background check disclosure and consent forms under state and federal laws, such as the Fair Credit Reporting Act and the Investigative Consumer Reporting Agencies Act. Existence of a criminal record is not an automatic bar to employment. An assessment will be made about whether the conviction has a direct and adverse relationship to the job in question. No job offer will be withdrawn, and no adverse action will be taken against any employee, based on the results of a criminal conviction background check, without an individualized assessment of whether the applicant’s conviction history has direct and adverse relationship with the specific duties of the job in question.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.BENEFITSAt 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 VETERANSMizuho 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 DISABILITIESIf 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.

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