Regulatory Affairs oversees compliance activities for customers. This covers reporting, tracking and improving compliance with regulations and laws pertaining to the manufacture, marketing and development of regulated products.

What you will be doing:

• Write, analyze, and edit technical documents to support country-specific regulatory submissions and compile submissions in a format consistent with applicable guidance documents, including investigational device submissions in USA, Canada and Europe.

• Work with other departments and communicate the submission requirements when documents are needed for regulatory submission.

• Maintain regulatory files. Maintain and update regulatory authorizations, such as IDEs, 510(k)s, Canadian medical device licenses, and CE dossiers for EU, NRTL certifications, etc.

• Assure that appropriate maintenance of registrations occurs including renewals, device listings, site registrations, supplements for changes, and annual reports. Support approval in other regions as required.

• Assist in preparing responses to regulatory authorities' questions within assigned timelines. 4. Stay abreast of regulatory procedures and changes in the regulatory climate.

• Assess device-related incidents/complaints for medical device reporting requirements.

• Handle recalls and field actions, if required.

• Support external regulatory agency audits, providing regulatory input to minimize the potential for findings of non-compliance.

• Assist in audit preps

• Responsible for communicating with agencies for any Notification, Field actions, Adverse Events, Significant/Non-Significant Changes, etc

• Have a detailed understanding of Product life cycle management

What your background should look like:

• Bachelor’s degree (BS, BA)

• Currently have or pursuing a Master in Regulatory Affairs

• 4 years' Regulatory experience.

• Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.

• Ability to work effectively within a team in a fast-paced changing environment.

• Multi-tasker and Quick Learner

• Strong verbal and written communication with the ability to effectively communicate at multiple levels in the organization.

Competencies