RA Specialist 4

About Company

Mizuho 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 Summary

The 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.
• Requires 8 years eexperience in Medical Device industry.
• Bacheloe's degree in business or related field; or equivalent combination of education and experience
• Working Knowledge of 21 CFR and FDA guidelines (GMPs) and international regulatory requirements.
• Excellent Computer Skills – MS Word, Excel, Power Point

• 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.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Annual Salary: $98k - $120k and 8% MBO

This is a hybrid position.