Sr. Regulatory Affairs Specialist

Glaukos Corporation•Burlington, MA

5d•Hybrid

About The Position

The Sr. RA Specialist is responsible for the preparation of regulatory submissions (domestic and foreign) and ensuring the implementation and maintenance of regulatory filings in compliance with applicable regulations and Glaukos internal SOPs. This role involves assisting with various FDA submissions, supporting recurring regulatory reports, preparing and maintaining essential documentation, and coordinating with regulatory agencies. The specialist will also research regulatory information, maintain regulatory files, and assist with audits. Additionally, the role supports field actions, participates in training, and coordinates with Clinical and R/D staff to ensure regulatory compliance.

Requirements

5-7+ years of experience with preparing medical device regulatory submissions, including but not limited to IDE, PMA, 510 (k), etc.
Knowledge of FDA guidelines for regulatory submissions and correspondence and detailed knowledge electronic submission requirements.
Minimum of Bachelor’s Degree in combination with a minimum of 5 years of Regulatory Affairs Experience in industry is required.
Proficient in MS Word and Adobe Acrobat.
Good communication skills.

Nice To Haves

Experience with combination products is a plus.
Experience in Ophthalmology is a plus.

Responsibilities

Preparation of regulatory submissions (primarily domestic).
Ensure implementation and maintenance of regulatory filing in compliance with applicable regulations and Glaukos internal SOPs.
Assists with preparation of 510(k), IDE's, PMA regulatory submissions required by FDA.
Assists with FDA establishment registration and device listing submissions.
Support recurring US regulatory reports/requirements (e.g. PMA annual reports).
Prepare and maintain required materials including but not limited to: FDA export certificates (CFG) requests, Document legalization, License renewals (including state licenses), Country approval list, Other regularly maintained registrations and licenses.
Support international registrations as requested.
Internal review of labeling, advertising, and document change orders as needed.
Coordinate information requests from FDA and international regulatory agencies.
Research scientific and regulatory information in order to write, edit, and review reports.
Compile materials required for submissions, license renewals, and annual registrations.
Keep informed of professional and global regulatory information.
Work with state and governmental regulatory agencies.
Maintain regulatory files and associated spreadsheets, reports, documents.
Assist team members with internal audits, customer audits, and third party audits, including those by US and international regulatory agencies.
Assist with other basic Regulatory Affairs functions, such as scanning and archiving records.
Field action support (documentation generation, shipment, customer contact, required reporting, effectiveness, follow-up, closeout).
Participate in company training programs that maintain appropriate awareness and compliance with ISO and CFR requirements.
Interact and coordinate with Clinical staff to facilitate clinical studies regulatory compliance.
Interact and coordinate with R/D staff to ensure compliance with applicable Design Control Requirements.