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At a glanceSummarised by Seekless from the posting.
Must have8
Minimum Bachelor's degree in Sciences, Engineering or equivalent
A minimum of ten years' regulatory experience
Proven experience in leading FDA BLA and sBLA CMC submissions and FDA medical device submissions including 510(k)'s and Q-subs
In-depth experience in dealing with FDA and international medical device regulatory agencies
Expert regulatory knowledge within relevant therapy area (Biologics, HCT/P's and device-led combination products)
Ability to work strategically within complex, business critical and high-profile programs
Ability to think strategically and critically evaluate risks to regulatory activities
Must demonstrate strategic thinking with ability to influence, strong initiative, work ethic and excellent oral and written communication skills
Nice to have1
Experience and knowledge on Sec 361 regulated Human Cells, Tissues, and Cellular and Tissue-Based products (HCT/P) highly desired
Benefits
401(k) matching
Tuition reimbursement
Flexible PTO
Health insurance
Dental insurance
Vision insurance
Employee assistance program
Parental leave
Adoption assistance
Hybrid work
About the role
Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. Reporting to the Senior Vice President Global Regulatory Affairs and Commercial Quality the Director Regulatory Affairs Wound will develop and implement global regulatory strategies in support of business objectives, provide strong leadership to their regulatory team and other cross functional team members.
What will you be doing?
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The Director will lead the regulatory strategy for the Advanced Wound Bioactives (AWB) portfolio of products that include Sec 351 regulated Biologic products, Sec 361 regulated Human Cells, Tissues, and Cellular and Tissue- Based products (HCT/P) as well supporting the NPD portfolio of device-led combination products.
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Responsible for leading a regulatory team spread across two locations (Fort Worth, TX and Columbia, MD). This includes developing and mentoring the RA department to build an effective and efficient responsive team.
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Lead the regulatory team in development of regulatory strategies for 510(k), sBLA and Health Canada submission and approvals.
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Participate and support FDA audits/inspections to maintain all necessary certifications/approvals and ensure compliance with applicable regulations.
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Champions a culture of collaboration, leadership, mutual accountability, critical thinking and continuous improvement within a high-performing team. Represents Regulatory Affairs with excellence in cross-functional interactions and represent Business RA with excellence in interactions with regional RA representatives.
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Responsible for assuring compliance with all relevant laws and regulations, domestic and international.
What will you need to be successful?
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Minimum Bachelor’s degree in Sciences, Engineering or equivalent.
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A minimum of ten years’ regulatory experience required
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Proven experience in leading FDA BLA and sBLA CMC submissions and FDA medical device submissions including 510(k)'s and Q-subs.
•
Experience and knowledge on Sec 361 regulated Human Cells, Tissues, and Cellular and Tissue-Based products (HCT/P) highly desired.
•
In-depth experience in dealing with FDA and international medical device regulatory agencies.
•
Expert regulatory knowledge within relevant therapy area (Biologics, HCT/P’s and device-led combination products)
•
Ability to work strategically within complex, business critical and high-profile programs.
•
Ability to think strategically and critically evaluate risks to regulatory activities.
•
Must demonstrate strategic thinking with ability to influence, strong initiative, work ethic and excellent oral and written communication skills.
You Unlimited.
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Inclusion + Belonging: Committed to Welcoming, Celebrating and Thriving. Learn more about our Employee Inclusion Groups on our website https://www.smith-nephew.com/
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Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement
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Work/Life Balance: Flexible Personal/Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service Day
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Your Wellbeing: Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program
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Flexibility: Hybrid Work Model (For most professional roles)
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Training: Hands-On, Team-Customized, Mentorship
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Extra Perks: Discounts on fitness clubs, travel and more!
Legal
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.
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About the company
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