Senior Regulatory Affairs Specialist (Smith & Nephew, Inc., Memphis, TN):

Prepare regulatory submissions such as: 510(k), technical files, design dossiers for new and modified devices. Work closely with project teams 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 for new and modified products. Plan and prepare international dossiers for New Product Development Key strategic markets to obtain and maintain global regulatory approvals of products to meet company product launch times. Ensure distribution of products within SAP comply with regulatory requirements and liaise with Regulatory PLD specialist to provide updates to licensing.

MINIMUM REQUIREMENTS:

Bachelor's degree in Pharmaceutical Science, Biomedical Engineering, Chemistry or a related field plus 5 years of post-baccalaureate experience in the job offered or related role in the Medical Device industry.

Of the required experience, must have 5 years of experience in Regulatory Affairs.

Of the required experience, must have 3 years of experience in each of the following:

• Providing Regulatory Affairs support to Product Development.
• Providing Regulatory Affairs support in Design Control Processes.

Of the required experience, must have 2 years of experience in the following:

• Writing EU MDR Technical Dossier submission(s).
• Regulatory compliance requirements, such as 21 CFR 820, ISO 13485:2016, EU MDR and cGMP.

Of the required experience, must have 1 year of experience in writing US 510(k) Submission(s).

Telecommuting permitted.

Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.