Job Description

JOB SUMMARY :

Under minimal supervision, responsible for implementing and maintaining international and domestic documentation for new and existing products. Responsible for completing and assuring proper documents when notifications are made for product changes resulting from manufacturing or design changes. Will participate in Design and Development activities to bring both a technical and regulatory point of view. Will coordinate, compile and assist in regulatory submissions to the US FDA, the Notified Body and other global regulatory agencies. Will assist management on external audits and the interdepartmental system improvements. Participate in processes and prepare materials required to be maintained for Microline Surgical’s quality system.

ESSENTIAL FUNCTIONS : The incumbent may be required to perform all or a combination of the following essential functions as determined by business necessity:

• Coordinate the preparation and maintenance of submissions to FDA, letters to file, technical files for the Notified Body and other submissions/materials for global regulatory agencies as required.
• Participate in compliance activities, such as internal audits, FDA and Notified Body audits, complaint handling and vendor audits.
• Assist in preparing or updating documentation and labeling as required.
• Assist in coordinating regulatory documentation such as device listings, certificates to foreign governments and Canadian medical device licensing.
• Prepare materials for Management Review Meetings.
• Prepare outlines, summaries, status reports, graphs, charts, tables and other materials, as necessary.
• Prepare and maintain the regulatory product classifications and groupings for new products within the context of the Medical Device Directive.
• Embed with Design/Development teams to provide both technical and RA input with a view to ensuring that design documentation resultant from the design-development process can be utilized for 510(k) and Technical Files with minimal (to no) modification.
• Understand and participate in technical discussions regarding product design.
• Review and challenge, if necessary, design and design change ECOs.
• Write technically compelling essays to submit to FDA to prove substantial equivalency.

NON-ESSENTIAL FUNCTIONS: In addition to the essential functions listed above, the incumbent may be required to perform other non-essential functions. Employees are required to follow any other job-related instructions and to perform any other job-related duties as requested by their supervisor.

QUALIFICATIONS

• BS/BA, preferably in regulatory affairs or science, Masters in Regulatory Affairs preferred
• Five years of direct work experience in medical device regulatory affairs is required.
• Excellent organizational, technical writing and communication skills.
• Proficiency with Microsoft Office.
• Team player and self-starter.
• Knowledge of ISO 13485, 21 CFR Part 820, MDSAP, and EU MDR
• Experience as an internal, supplier, or external auditor
• Experience working in or with a FDA registered manufacturing facility
• Experience drafting 510(k) documentation and EU Technical Documentation
• Experience with Adverse Event Reporting
• Experience with Corrective and Preventive Actions
• Experience with various types of preclinical testing, such as biocompatibility, electrical safety, and useability
• Preferred qualifications:
• Experience as an external audit host
• Experience with international regulatory submissions (non-US/EU)
• Experience working directly with FDA
• Experience with product design controls
• Experience with post-market clinical feedback development
• Project management experience
• Lean Six Sigma experience and/or certification
• RAC certification

REASONABLE ACCOMMODATION: Microline Surgical is committed to the spirit and letter of the Americans with Disabilities Act and, as required by law, will reasonable accommodate otherwise qualified individuals.

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