Sr. Regulatory Affairs Specialist

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.

Generous. Innovative. Leadership-driven. Family-oriented. Socially responsible.

Founded in 1998, Glaukos Corporation is an ophthalmic pharmaceutical and medical technology company focused on developing and commercializing novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases.

Our mission at Glaukos is to truly transform vision by pioneering novel, dropless therapies that can meaningfully advance the standard of care and improve the lives of patients suffering from chronic, sight-threatening eye diseases.

Innovation is at the core of everything we do, and we are resolute in our commitment to challenge conventional thinking with new treatment alternatives that are supported by real science, robust clinical evidence, and an unrelenting focus on patients.

Our constant pursuit of game-changing technologies that disrupt legacy treatment paradigms is encapsulated in the Glaukos mantra "We'll Go First," which articulates our willingness to take chances, our determination to forge new ground, and our commitment to continuous improvement in all that we do.

Our company completed an initial public offering in June of 2015, and our shares are traded on the New York Stock Exchange under the ticker symbol "GKOS". Our global headquarters is in Aliso Viejo, California with additional locations in San Clemente, California, and Burlington, Massachusetts.

Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.

All offers of employment are contingent upon the successful completion of a background check, including successfully passing a drug screen, based on the position and local regulations.

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

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