Regulatory Affairs Manager

 Is the Regulatory Affairs representative for company's programs and assists with regulatory issues related to such items as labeling and marketing ideas, prepares documents required in the Development Life Cycle, and recommends strategies for most efficient and effective approvals of regulatory applications for the business.

 Supports the cross functional teams with regulatory guidance during all design control phases of a new product or major/minor changes

 Coordination and preparation of document packages for regulatory submissions to the US, EU CE mark, Canada [510(k) Pre-market Notifications, Product Reports /Supplements, US Device Listings, GUDID (UDI), Technical Documentation in compliance with EU MDR 2017/745/EU, Declarations of Conformity, NMPA, ANVISA] .

 Provides guidance on global compliance, such as CE Marking and product registrations, clinical evaluations in accordance with ISO 14155, Canada Medical Device Regulations, etc, applicable standards and product labeling.

Requirements:

 Bachelor’s degree in a technical / healthcare / business discipline or equivalent.

 At least 6 years of relevant experience in a medical device company (FDA Class II– Class III a plus).

 Experience with successful preparation and submission of 510(k), PMA, or international documents or registration and marketing of medical device worldwide.

 Strong working knowledge of medical device regulations (21CFR) and FDA law, MDSAP, MDR 2017/745/EU

 Excellent English skills (written and oral).

Desired Qualifications:

• Certified regulatory affairs professional would be desirable.

• Experienced in design control process.

• Experience in supporting international registrations desirable