Hybrid Senior Regulatory Affairs Specialist

at Smith+Nephew

• Job title: Senior Regulatory Affairs Specialist
• Job type: Full Time
• Experience level: Senior
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Austin, United States

About the role

• Lead regulatory strategies and prepare US 510(k), PMA/HDE and EU MDR submissions for Smith+Nephew orthopedic devices.

Responsibilities

• Prepare and review 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 preparation of international regulatory submissions for new and modified devices
• Serve as RA lead on project teams to develop regulatory strategies, testing requirements and documentation to meet product launch timelines
• Manage/lead regulatory-driven projects and execute global regulatory strategies for product release and market expansion
• Maintain knowledge of global regulations, standards, guidance documents, country-specific requirements, internal procedures, medical devices and medical terminology
• Maintain computer databases for cleared/approved product release, UDI database accuracy, and submission tracking/metrics
• Plan, lead and support internal and Regulatory agency audits and engagement with regulatory authorities
• Lead regulatory assessments for engineering change requests and manage updates to registrations
• Develop and maintain company global and local SOPs to assure regulatory compliance
• Provide technical guidance and regulatory training/mentoring to Regulatory Affairs employees and cross-functional teams
• Develop/review product labeling (IFUs, PICs, PILs), Surgical Techniques and promotional materials for regulatory compliance

Requirements

• Bachelor’s degree preferably in a clinical, medical, or scientific/technical discipline (Biomedical engineering preferred)
• Minimum of 5 years regulatory experience within the medical device industry
• Orthopedic device experience desired
• 510(k) experience is required
• PMA/HDE experience preferred
• Demonstrated experience with successful regulatory submissions in key markets such as the 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)
• Ability to write detailed technical regulatory submissions, reports and business correspondence
• Willingness to travel: <10%
• Position does NOT offer visa transfer or sponsorship (must have work authorization)

Benefits

• 401k Matching Program
• 401k Plus Program
• Discounted Stock Options
• Tuition Reimbursement
• PTO (Paid Time Off)
• 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 (For most professional roles)
• Discounts on fitness clubs, travel and more