Regulatory Affairs Specialist II

The Regulatory Affairs Specialist II will execute regulatory activities to support currently marketed devices and new product development in the DePuy Synthes Joint Reconstruction and VELYS Digital Surgery line of products. This role involves a multi-faceted set of skills including sound regulatory judgment, cross-functional collaboration, and planning/oversight/execution of projects & activities that directly impact the operational results of the business.

You will be responsible for:

In accordance with all applicable federal, state and local laws/regulations and Corporate

Johnson & Johnson, procedures and guidelines, this position will:

• Prepare and/or assist in preparation of regulatory documentation for DePuy devices, including IDE, 510(k), PMA, Technical File, Design Dossier, and Technical Documentation for submission to regional Health authorities. This includes the resolution of regulatory issues and questions from regulatory agencies during the pre-market product development phase interacting with regulatory agencies regarding submissions.

• Assist in the preparation of approval documents to support rest of world registrations, such as EU CE marking activities, as required.

• Review engineering changes to currently marketed products and prepare internal regulatory assessments for documenting decisions to submit or not to submit in accordance with relevant regulations and guidance.

• Works with team members to determine regulatory impact of manufacturing and/or changes on products, prepare and submit applications, and the assess the impact product changes have on the status of regulatory licenses.

• Review product labeling and product support information for currently marketed products to ensure that product information and claims are consistent with premarket clearances and approvals and in compliance with relevant regulations and guidance.

• Provides product information and regulatory guidance and support to project teams including processing design control changes, providing guidance and review of promotional materials, and communicating regulatory pathways.

• Maintain current knowledge to ensure compliance to the applicable regulatory and corporate standards/requirements (FDA Quality System Regulations, European Quality Standards and

Medical Device Regulation, ISO 13485, previous MDD, MDR, etc.).

• Responsible for communicating business related issues or opportunities to next management level

• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.

• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable.

• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.

• Performs other duties assigned as needed.