Sr. Regulatory Affairs Specialist (Austin, TX)

Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.   

The Senior Regulatory Affairs Specialist role is responsible for preparing and supporting US and International regulatory submissions and regulatory strategies for the Smith+Nephew Extremity Orthopedic portfolio, which is comprised of joint replacement devices for the upper and lower extremities. This role will serve as a leader in the organization and amongst the project and regulatory teams requiring exemplary knowledge of regulatory requirements gained through experience and ability to perform the essential duties and responsibilities independently, with some direct supervision.

**This position is not offering any type of visa transfer or sponsorship now or in the future**

What will you be doing?

Preparation and review of global regulatory submissions, including US 510(k), US Class III Annual Reports, US PMA/HDE Supplements and EU MDR technical documentation, and support regional regulatory colleagues in the preparation of international regulatory submissions for new and modified devices.  This includes submissions, notifications, etc. for new devices, modified devices and any other changes requiring submission, registration updates, etc.

• Work as the RA lead on project teams independently to develop regulatory strategies, testing requirements and other documentation to assure that regulatory submissions are prepared and approved to meet the Company’s product launch timelines in all identified markets.

• Manage/lead regulatory-driven project(s), as directed by management.

• Develop and execute global regulatory strategies and support product release for market expansion activities for new and modified products.

• Maintain a working knowledge of global regulations, standards, guidance documents, country-specific requirements, internal procedures, medical devices and medical terminology (including, but not limited to US facility registration, device listing, import/export and UDI).

• Maintain computer databases to ensure only cleared/approved products are released for commercial distribution; accurate data attributes are reflected in the applicable UDI database; reflect planned, in-process and completed regulatory submissions/regulatory impact assessments for tracking and metrics.

• Plan, lead and support internal and Regulatory agency audits.

• Lead and direct engagement with regulatory authorities, as required.

• RA lead for engineering change requests/notifications; initiate and manage regulatory change assessments (e.g., design, labeling, manufacturing process changes) to determine impact to domestic and international product registrations in alignment with FDA and international government regulations, update registrations as required to maintain regulatory submission compliance.

• Develop and maintain company (global and local) Standard Operating Procedures (SOPs) intended to assure compliance with applicable global regulatory requirements, as needed.

• Support departmental infrastructure development and maintenance.

• Provide technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams.

• Develop/author product labeling (including, but not limited to, IFU’s, PIC’s, PIL’s) in alignment with applicable regulatory requirements.
• Review product labeling, Surgical Techniques and promotional materials to ensure compliance with FDA and international requirements, as well as approved product claims.
• Other activities as assigned.

What will you need to be successful?

• Education:  Bachelor’s degree preferably in a clinical, medical, or scientific/technical discipline. Biomedical engineering degree preferred but not required.
• Experience and Skills: 
• Minimum of 5 years regulatory experience within the medical device industry is required.
• Orthopedic device experience desired
• 510K experience is required
• PMA/HDE experience preferred
• Demonstrated experience with successful regulatory submissions in key markets such as US as EU.
• Demonstrated knowledge of regulatory requirements, standards and guidance for medical devices.
• Experience working with large cross functional teams and diverse groups.
• Processes and Product Lifecycle Management Systems experience is required.
• Knowledge of regulatory compliance requirements (e.g. 21 CFR 820, ISO13485:2016,  EU MDR, GMP etc).
• Ability to write detailed technical regulatory submissions, reports and business correspondence