Develop US and EU regulatory strategies for product submissions, identifying needs for bench, animal and clinical testing.
Assist in keeping company informed of regulatory requirements in the US and EU.
Participate on Product Development teams by providing regulatory strategy, timelines, and direction.
Prepare US and EU submissions. Work with Notified Body and FDA to obtain product approval/clearance. Ensure relevant ISO and FDA requirements are met, as required.
Review Change Orders and assess regulatory impact of product changes on US and/or EU regulatory strategy and submissions per standard procedures.
Review labeling, training, promotional and advertising material.
Support post market regulatory compliance activities for US/EU product approvals.
Develop and maintain regulatory affairs department procedures and process improvements.
Comply with applicable FDA and international regulatory laws/standards and the Code of Conduct.
Assist in keeping company informed of regulatory requirements in the US and EU.
Requirements:
5+ years of US/EU medical device regulatory submission experience with Bachelor's degree
510(k) or PMA submission experience
Knowledge of FDA and EU requirements
Strong communication skills
Strong technical writing skills
Regulatory Affairs Certification
Master's degree in Regulatory Affairs or Engineering