Regulatory Affairs Advisor Medical Advice
Company: Robsco Search
Posted on: April 27, 2021
Prepare regulatory assessments and plans for new products and
design changes. Prepare or direct the preparation of regulatory
submissions for product approval/clearance, including 510(k)
premarket notifications. Participate in interactions with
regulatory agencies needed to obtain product approval/clearance.
Support Investigational Device Exemption submissions. 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. 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 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
post-market regulatory compliance activities for US and
international products. Qualifications: Education: BS or higher
degree in engineering, science, health care or similar required.
Experience: 10+ years regulatory experience with at least 5 years
regulatory experience in Medical Devices, including demonstrated
experience in preparing successful FDA 510(k) submissions.
Experience in preparing international submissions is a plus.
Experience in acting as a liaison to and communicating with
regulatory agencies. Akron, Ohio. Must possess strong oral and
written communication skills.
Keywords: Robsco Search, Quincy , Regulatory Affairs Advisor Medical Advice, Healthcare , Quincy, Massachusetts
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