Sr. Regulatory Affairs Specialist

Company: Nihon Kohden OrangeMed Inc.

Position: Sr. Regulatory Affairs Specialist

Location: Santa Ana. California

Posted: November 9, 2020

Job Purpose

Responsible for providing support for the regulatory department to ensure efficient and compliant business processes and environment. The individual may assist in identifying data needed, obtaining the data, and ensuring that data is effectively presented for the registration of products worldwide and design assurance.

Duties and responsibilities
• Assumes responsibility for Design Assurance of Nihon Kohden OrangeMed, Inc. Products and Accessories
o Assure compliance with Design Control policies and procedures.
o Work with engineering to make sure design history files and technical files are kept current.
o Review and approve changes to Design, Software, QMS or Product Range by assessing impact on design and processes from a regulatory standpoint.
o Assure compliance with Risk Management policies and procedures.
o Provide regulatory input to product lifecycle planning.
o Participate in risk benefit analysis for regulatory compliance.
o Work with engineering to document the analysis of new or modified risks due to design, software, or process changes.
o Reviews labeling (Instruction for Use, labels, promotional materials) for compliance to standards, guidelines, regulations, and regulatory approvals/clearances.

• Assumes responsibility for working with Nihon Kohden Sales Offices worldwide to obtain country specific product approvals
o Maintenance of shared regulatory directory to ensure dissemination of current information.
o Assist in the fulfillment of any special regulatory needs as requested from any of the Nihon Kohden Sales Offices.
o Request Certificates of Foreign Governments (CFG) and various types of “Authentications” from the US State Department and foreign embassies.

• Assumes responsibility for preparing US regulatory submissions
o Responsible for assisting in the preparation and compilation of domestic and international product registration submissions, with guidance. This includes, but is not limited to, 510ks, international dossiers and CE technical files.
o Monitor submissions under review and coordinate timely response to any questions/request for information from FDA.

• Assumes responsibility for compliance with Regulatory Reporting requirements
o Support medical device reporting, vigilance and recall related activities.
o Monitor and work with complaint department to submit applicable reports to regulatory authorities.
o Ensure product safety issues and product associated events are reported to regulatory agencies.
o Ensure compliance with product post marketing approval requirements.
o Lead Production and Post Market Surveillance Team and ensure timely preparation of any required Post-Market Surveillance Reports.

• Monitor and understand changes to the regulatory environment, including relevant domestic and international standards, regulations, and guidance documents. Implement such changes as required.
• Provide support to audits and inspections by regulatory agencies as needed.
• Adheres to all company policies, procedures, and business ethics codes.
• Mentor other team members throughout the organization through subject matter expertise and experience.
• Other duties as assigned.

• Bachelor’s degree in Engineering or other scientific discipline with 5+ years of regulatory. affairs experience in medical device industry.
• Proficient understanding of US FDA and EU Medical Device regulatory requirements.
• Knowledge of quality system requirements such as ISO 13485 and FDA’s 21 CFR Part 820.
• Knowledge of product development processes in medical device industry.
• Must be computer-savvy and well-versed in Microsoft Office products.
• Effective technical writing and verbal communication skills.
• Strong communication, presentation, and interpersonal skills.
• Great attention to detail with excellent organizational and coordination abilities.
• Self-directed, the ability to work independently, and being highly motivated.
• Ability to function in a fast-paced and deadline driven environment.
• Fluent in English (fluency in other languages are a plus).

Desirable Accreditations/Knowledge
• Completion of relevant Professional Development Program (e.g. UCI Regulatory Affairs and Compliance) or equivalent work experience
• RAC certification is a plus

Working conditions
• The Sr. Regulatory Affairs Specialist usually works in an office environment which includes laboratory and manufacturing areas. Occasional travel may be required.
• The Sr. Regulatory Affairs Specialist works a standard work week but may be required to work some evenings and weekends to meet the needs of the company.

Physical requirements
• Must be able to type using the keyboard of a computer.
• Must be able to talk, listen and speak clearly on the telephone.
• Must be able to lift and carry up to 50 lbs.