Regulatory Affairs Specialist
Glaukos is a rapidly growing international ophthalmic medical technology company focused on the development and commercialization of breakthrough products and procedures designed to transform the treatment of glaucoma, one of the world's leading causes of blindness. We have pioneered Micro-Invasive Glaucoma Surgery, or MIGS, to revolutionize the traditional glaucoma treatment and management paradigm. We launched the iStent, our first MIGS device, in the United States in July 2012 and we are leveraging our 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. We believe the iStent is the smallest medical device ever approved by the Food and Drug Administration, or FDA, measuring 1.0 mm long and 0.33 mm wide.
The Regulatory Affairs Specialist/Senior Specialist based in Japan will be responsible for preparation of regulatory submissions (domestic and foreign) and to ensure implementation and maintenance of regulatory filing in compliance with applicable regulations and Glaukos internal Standard Operating Procedures.
Essential Duties and Responsibilities:
- Coordinate and prepare submission documents for the registration of new products and changes to existing products in partnership with Corporate Regulatory Affairs.
- Work closely with Corporate Regulatory Affairs in the preparation of post-approval submissions (ie. Partial change approval applications/minor change notifications), PMA, IDE, IND and NDA regulatory submissions required by PMDA for new and modified medical devices/drugs.
- Coordinate and assist in facilitating Regulatory Agency Meetings.
- Prepare and submit recurring international regulatory reports/requirements (e.g. PMA annual reports).
- Prepare and maintain required materials including but not limited to:
oLicense renewals (including state licenses)
oCountry approval list
oOther regularly maintained registrations and licenses
- Assist with Internal review of labeling, advertising, and document change orders as needed
- Interact with PMDA and MLHW as directed by management to coordinate and facilitate regulatory submissions and agency meetings
- Act as main DMAH regulatory contact for PMDA and MLHW interactions and communications
- 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.
- Maintain regulatory files and associated spreadsheets, reports, documents.
- Assist team members with internal audits, customer audits, and third party audits, including those by international regulatory agencies (ie. PMDA).
- Assist with other Regulatory Affairs functions, such as formatting, scanning and archiving records.
- Participate in company training programs that maintain appropriate awareness and compliance with ISO, CFR and country-specific requirements
- Interact and coordinate with Clinical staff to facilitate clinical studies regulatory compliance
- Interact and coordinate with Corporate Regulatory Affairs and Quality staff to ensure compliance with applicable Design Control Requirements
- May perform other duties as assigned
At least 3 years' experience in Regulatory affairs in the Medical Device field is required; exposure to pharma industry is a plus. Experience with working with PMDA and pharmaceutical regulatory affairs is a plus.
- Team Player, adaptability, hand-on minded, problem solving minded; ownership
- Critical thinking, ability to determine root cause, to generate multiple solutions
- Strong communication and writing skills
- Well organized, self-motivated and dependable
- Open to directions and constructive feed-back
- Willing to be part of a small fast growing organization
- Able to read, write and speak English
Required Education & Experience:
B.A/B.S in life sciences or technical (engineering) or related field (or non-US equivalent). Regulatory Affairs certification (RAC) is a plus.
Glaukos Corporation is an Equal Opportunity/E-Verify/Affirmative Action employer.
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