Job Description

IRIDEX Corporation is a medical device manufacturer and operates in a global regulated environment (e.g. FDA). Regulations
include (but are not limited to) FDA 21 CFR 820, EN ISO 13485, and the European Medical Regulation (MDR). Based on the
position, experience in a regulated environment and the extent of working knowledge of appropriate regulations may vary.

PURPOSE OF JOB:

The  Regulatory Affairs Associate, Compliance Documentation is responsible for (1) coordinating, preparing, compiling and maintaining various regulatory documentation, including documentation used in local and regional registration, license renewal and product submissions for mature product, and (2) continuous and timely communications with international distributors to assure that the regulatory requirements of International Distributors are met.
The Regulatory Affairs Associate, Compliance Documentation reports to the RA Supervisor– Compliance, International, and Documentation, and will work with the Iridex Team and consultants to obtain, prepare, and provide information in support of regulatory submissions, listings, registrations, licensing, and periodic updates, including the coordination and preparation of document packages for regulatory submissions for new product.
This position will help maintain regulatory documentation and procedures, and may direct interaction with regulatory agencies on defined matters.

MAJOR DUTIES AND RESPONSIBILITIES:

• Administer regulatory documentation
  o Assist in preparation of domestic eCopies and other documentation for submission to government and other agencies (including United States and outside U.S. agencies), and for submission to distributors.
  o Assist in regulatory registrations including registrations for establishment, product and product labeling, including obtaining and maintaining relevant documentation.
  o Work with Supervisor to update US FDA, EUDAMED, and other databases
  o Obtain government certificates as necessary for various submissions/distributor requests
  o Maintain international approval history of products and establishment.
  o Maintain regulatory files/database and chronologies.
  o Maintain history of submissions and interactions with regulatory agencies and regulatory partners such as Distributors and etc.
• Serve as point of contact for International distributors
  o Support regional registration requirements, including supporting the introduction of new products, the maintenance of existing and changing products
  o Communicate product changes to International distributors and their regulatory personnel and coordinate the necessary activities to successfully implement the proposed changes in the individual International markets.
  o Coordinate timely compilation of materials for license renewals, updates and registrations
• Communicate International requirements to Iridex Team
  o Interact with Engineering, Customer Service, Purchasing, Document Control, and Quality Control to obtain documents and test data necessary to support regional registration requirements
  o Update team of changes to requirements
• Prepare/assist in preparation of International regulatory submissions, contracts and tenders:
  o Plan, coordinate, and prepare / assist in the preparation of International regulatory submissions, including international dossiers and other registration filings.
  o Assist with registration, listing, technical dossiers, MDD certification.
  o Prepare and coordinate certified, notarized, legalized and apostilled documentation.
• Support Quality Systems as they affect Regulatory
  o Perform procedure review and prepare updates
  o Support product investigations

QUALIFICATIONS:

• Education: 4-year college degree preferred or 2 years relevant work experience.
• Experience: 1 to 4 years of experience in medical device industry preferred.
• Computer literate and proficient in Microsoft Office Suite and Adobe Acrobat.
• Notary public preferred but not required.
• Ability to maintain confidentiality of information and materials.

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