Sr. Specialist, Regulatory Affairs

The Senior Regulatory Affairs Specialist will be responsible for the development of submissions for domestic and international clearances; as well as the support of daily activities related to new product development, change control, and regulatory product submissions.

Essential Duties and Responsibilities * Collaborates as a core team member on new product development teams.

Independently determines and documents appropriate regulatory strategy for proposed new products.

Supports design control activities.

Provides regulatory input to project timeline planning.

* Prepares regulatory submissions including 510(k) premarket notifications for US FDA * Prepares regulatory submissions including technical files/design dossiers for registration of products in MDSAP countries and interfaces as needed with Notified Bodies regarding significant changes to products.

* Responsible for internal process improvements, data/metric evaluation, maintenance of databases, and public-facing information.

* Critically reviews verification and validation reports, and other documents for scientific merit and to ensure adherence to regulatory requirements.

* Assists with post market surveillance evaluation, trending, and reporting including updates to risk management (e.g., FMEA) process.

* Reviews product labeling and promotional materials to ensure consistency with regulatory approvals/clearances.

* Reviews nonconformances and deviations and provides regulatory guidance and expertise.

* Provides mentorship to less senior regulatory team members.

* Researches sources of regulatory information (e.g., regulatory agency websites, standards organization websites, literature, trade sheets, competitor information, etc.). * Provides department support during internal and external audits.

* Assists in developing, maintaining, assigning, and tracking company Standard Operating Procedures (SOPs) to ensure compliance with applicable global regulatory requirements.

* Maintains FDA establishment listings and registration.

* Demonstrates continuous pursuit of regulatory knowledge to obtain experience and expertise in product submissions and regulatory topics, including FDA regulations, 510(k)s, labeling and promotional materials, 21 CFR 820, 21 CFR 1271, global medical device registration, technical writing, and external standards.

* Other duties as assigned.