Sr. Regulatory Affairs Specialist (Austin, TX)

Smith & Nephew-posted 3 months ago
Full-time • Mid Level
Hybrid • Memphis, TN
5,001-10,000 employees
Miscellaneous Manufacturing
Resume
Match Score
Upload and Match ResumeTrack Jobs with Teal

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.

  • 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.
  • Support regional regulatory colleagues in the preparation of international regulatory submissions for new and modified devices.
  • 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.
  • Maintain computer databases to ensure only cleared/approved products are released for commercial distribution.
  • 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.
  • Develop and maintain company (global and local) Standard Operating Procedures (SOPs) intended to assure compliance with applicable global regulatory requirements.
  • 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 in alignment with applicable regulatory requirements.
  • Review product labeling, Surgical Techniques and promotional materials to ensure compliance with FDA and international requirements.
  • Bachelor's degree preferably in a clinical, medical, or scientific/technical discipline; Biomedical engineering degree preferred but not required.
  • Minimum of 5 years regulatory experience within the medical device industry.
  • Orthopedic device experience desired.
  • 510K experience is required.
  • PMA/HDE experience preferred.
  • Demonstrated experience with successful regulatory submissions in key markets such as US and 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.
  • 401k Matching Program
  • 401k Plus Program
  • Discounted Stock Options
  • Tuition Reimbursement
  • PTO
  • Paid Holidays
  • Flex Holidays
  • Paid Community Service Day
  • Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually)
  • Employee Assistance Program
  • Parental Leave
  • Fertility and Adoption Assistance Program
  • Hybrid Work Model
  • Hands-On, Team-Customized Training
  • Mentorship
  • Discounts on fitness clubs, travel and more
Track Jobs with Teal

Job Search Resources

•
Resume Builder
•
Resume Examples
•
Cover Letter Examples

Tools

Career Hubs

Guides

Company

© 2024 Teal Labs, Inc
Privacy PolicyTerms of Service