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Software Application Development

Medical Device Principal Regulatory Affairs Specialist

$111k – $140k
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Overview

Drive regulatory excellence at our Healthcare Optics Research Laboratory for our biomedical devices in collaboration with world-leading medical institutions. We are seeking an experienced Medical Device Principal Regulatory Affairs Specialist (Advisor, Regulatory Affairs) professional who will define and execute the regulatory plans to obtain and maintain regulatory approvals within the US and international markets.

Responsibilities

Participate on product development Core Teams assisting with regulatory assessments and planning; reviewing product development and clinical protocols and reports to ensure collection of appropriate data for regulatory submissions; and participating in risk assessments and design reviews
Prepare regulatory assessments and plans for new products and design changes
Preparation of regulatory submissions for product approval/clearance, including 510(k) premarket notifications
Lead interactions with regulatory agencies needed to obtain product approval/clearance
Review labeling, training, and promotional materials for compliance with claims and applicable regulations
Assess product and manufacturing changes to determine regulatory impact
Provide ongoing surveillance and analysis of FDA and international medical device regulations for impact on Canon products and regulatory procedures
Communicate regulatory requirements to management, Core Teams and others; particularly new and revised regulatory requirements
Develop and maintain regulatory procedures and policies to ensure compliance to applicable regulations
Support US and international product registrations
Support Investigational Device Exemption submissions
Support post-market regulatory compliance activities for US and international products
Qualifications

BS or higher degree in engineering, science, health care or similar
10 years medical device experience, including demonstrated experience in preparing successful domestic and international submissions
Experience in acting as a liaison to and communicating with regulatory agencies
Strong working knowledge of FDA and EU MDR (European Medical Device Regulation) medical device regulatory requirements
Knowledge of Japanese and other international regulations is a plus
MDSAP (European Medical Device Regulation) experience is a plus
RAC (Regulatory Affairs Certification) certification is a plus
Proficient in Microsoft Office
Must possess strong oral and written communication skills
The company will not pursue or support visa sponsorship for this position.

Bytelion at a glance

Software Application Development

Bytelion focuses on Software and Software Engineering. Their company has offices in Baltimore. They have a mid-size team that's between 51-200 employees.

You can view their website at https://www.bytelion.com

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