Glaukos

Sr. Regulatory Affairs Specialist

Glaukos • $97K — $122K *
Burlington, MA 01803In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • 5-7 years of experience in medical device regulatory submissions (IDE, PMA, 510(k))
  • Knowledge of FDA guidelines for submissions and electronic requirements
  • Experience with combination products is a plus
  • Minimum Bachelor’s Degree in a relevant field
  • Previous experience in Ophthalmology is advantageous

Responsibilities

  • Assist in preparing regulatory submissions mainly for FDA
  • Support the registration and listing of FDA establishments
  • Prepare annual reports and recurring regulatory submissions
  • Maintain necessary documentation for regulatory processes
  • Coordinate requests from FDA and international agencies
  • Conduct research for report writing and submission compilation
  • Collaborate with clinical and R&D staff for compliance

Benefits

  • Flexible working options with a hybrid schedule
  • Participation in company training programs for compliance
  • Engagement with a fast-growing organization in the medical device field
  • Opportunity for bonuses and other fantastic perks
  • Onsite work in Burlington, MA, fostering team collaboration
Full Job Description
Job Description

The Sr. RA Specialist is Responsible for preparation of regulatory submissions (domestic and foreign). Ensure implementation and maintenance of regulatory filing in compliance with applicable regulations and Glaukos internal SOPs.

Responsibilities

How You'll Contribute:

The Sr. RA Specialist is responsible for preparation of regulatory submissions (primarily domestic). Ensure implementation and maintenance of regulatory filing in compliance with applicable regulations and Glaukos internal SOPs.

What You'll Do:
  • 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

Other Duties:
  • 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.

How You'll Get There:
  • 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.
  • Experience with combination products is a plus.

Knowledge, Skills, and Abilities:
  • Team Player, adaptability, hand-on minded, problem solving minded
  • Critical thinking, ability to determine root cause, to generate multiple solutions
  • Well organized, self-motivated and dependable
  • Open to directions and constructive feed-back
  • Willing to be part of a fast growing organization
  • Proficient in MS Word and Adobe Acrobat
  • Good communication skills
  • Minimum of Bachelor's Degree in combination with a minimum of 5 years of Regulatory Affairs Experience in industry is required.
  • Experience in Ophthalmology is a plus.
  • This role works onsite in our Burlington, MA offices
  • Salary Range: 97,900.00 - 122,400.00 plus bonus and many other fantastic benefits and perks
  • Flexibility on salary range for the right experience
  • Hybrid - M-W-F onsite


About Glaukos

Glaukos Corporation is an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases. The company pioneered Micro-Invasive Glaucoma Surgery, or MIGS, to revolutionize the traditional glaucoma treatment and management paradigm. Glaukos launched the iStent, its first MIGS device, in the United States in 2012 and is leveraging its platform technology to build a comprehensive and proprietary portfolio of micro-scale injectable therapies designed to address the complete range of glaucoma disease states and progression. The company's second-generation MIGS device, the iStent inject, was approved by the FDA in June 2018. Glaukos is also developing a pipeline of innovative technologies in corneal health, including the recently acquired Microline surgical platform, as well as novel drug delivery technologies.
Learn more about Glaukos
Size
727 employees
Market Cap
$1.9 billion
Industry
Healthcare
Net Income
-$120.3 million
Founded
1998
5 Year Trend
+20.8%
Revenue
$224.9 million
NASDAQ
GKOS
* Ladders Estimates

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