Director, Regulatory Affairs – Regulatory Science and Execution
AstraZeneca
Senior Regulatory Affairs Specialist
Smith+Nephew
full-time
Posted on:
Location Type: Hybrid
Location: Austin • Massachusetts, Tennessee, Texas • 🇺🇸 United States
Visit company websiteJob Level
Senior
About the role
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory submissions510(k)PMAHDEEU MDRregulatory strategiestechnical documentationproduct labelingregulatory compliancemedical terminology
Soft skills
leadershipcommunicationmentoringcollaborationproject managementtechnical guidanceorganizational skillsattention to detailproblem-solvingcross-functional teamwork
Certifications
Bachelor’s degreeBiomedical engineeringISO 13485:201621 CFR 820GMP
