What are the responsibilities and job description for the Regulatory Specialist position at Instylla?
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About Instylla
Instylla, Inc. is a privately held medical device company based in Bedford, MA, focused on developing novel resorbable embolic agents to advance interventional radiology, with initial clinical applications in interventional oncology. Instylla was founded in 2017 by Incept LLC and is funded by several leading venture capital groups. The company’s flagship product, Embrace™ Hydrogel Embolic System, is FDA-approved for hypervascular tumor embolization and offers controlled, targeted, and persistent embolization.
Position Summary
The Regulatory Specialist supports the development, approval, and compliance of medical devices by preparing and submitting regulatory filings in alignment with organizational objectives and global requirements. The specialist collaborates cross-functionally, serving as a regulatory representative on product development teams to ensure regulatory requirements are understood and integrated.
Job Responsibilities
About Instylla
Instylla, Inc. is a privately held medical device company based in Bedford, MA, focused on developing novel resorbable embolic agents to advance interventional radiology, with initial clinical applications in interventional oncology. Instylla was founded in 2017 by Incept LLC and is funded by several leading venture capital groups. The company’s flagship product, Embrace™ Hydrogel Embolic System, is FDA-approved for hypervascular tumor embolization and offers controlled, targeted, and persistent embolization.
Position Summary
The Regulatory Specialist supports the development, approval, and compliance of medical devices by preparing and submitting regulatory filings in alignment with organizational objectives and global requirements. The specialist collaborates cross-functionally, serving as a regulatory representative on product development teams to ensure regulatory requirements are understood and integrated.
Job Responsibilities
- Support in the preparation and submission of regulatory submissions in accordance with organizational objectives
- Develop and maintain EU Technical Documentation
- Maintain device listings and registrations
- Assess complaint reportability and file adverse event reports when required
- Maintain/manage standards compliance
- Review engineering change orders and assess regulatory impact
- Act as a regulatory representative on product development teams and communicate regulatory requirements
- Monitor and maintain ongoing surveillance and analysis of pertinent domestic and international medical device regulations, standards and guidance
- Assist in maintenance of Quality Management System
- Conduct internal/supplier audits
- Maintain regulatory files and records
- Additional responsibilities as assigned
- BA or BS degree; Scientific or engineering field preferred.
- 1-2 years of technical experience, including at least 1 years of regulatory experience in a medical device industry
- Experience with 510(k), IDE, PMA applications and/or experience with EU and other international medical device submissions
- Must have knowledge of U.S. and/or European/International regulations and standards
- Experience in preparing regulatory submissions.
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
- Must demonstrate good technical writing skill
- Must work well in team environments
- Proficient on programs under Microsoft office; proficient in formatting submission documents
- Proven analytical abilities
- FDA 510k, PMA regulations
- EU MDR requirements
- RAC Certification (preferred)
- Long periods of time working on a computer
- Occasional travel as needed for regulatory meetings (up to 15%)