Director, Regulatory Affairs – AWB

Smith & Nephew; Fort Worth (TX); Hybrid; USD 180,000 - 230,000; Full time

Benefits offered by this job

401k Matching Program

Tuition Reimbursement

Hybrid Work Model

Parental Leave

Fertility and Adoption Assistance

Job summary

Smith+Naphew is seeking a Director of Regulatory Affairs to lead the Wound portfolio's regulatory strategy and manage a cross-functional team across Fort Worth, TX and Columbia, MD. The role focuses on securing timely approvals for 510(k), BLA/sBLA, and HCT/P submissions while ensuring compliance with global regulations.

Requires a minimum of a Bachelor's degree and 10+ years of regulatory experience, with proven capability in FDA submissions, international filings, and strong leadership and

Qualifications

• Bachelor's degree in sciences, engineering or equivalent.
• 10+ years of regulatory experience required.
• Proven experience in leading FDA BLA/sBLA submissions and 510(k) submissions.

Responsibilities

• Lead regulatory strategy for AWB portfolio and support NPD device-led products.
• Mentor and lead RA team across Fort Worth, TX and Columbia, MD.
• Drive FDA inspections, audits and global regulatory approvals.

Skills

Regulatory leadership

Strategic thinking

Cross-functional leadership

FDA interactions

Education

Bachelor's degree in sciences/engineering

Job description

Life Unlimited. At Smith+Naphew 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?

• 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.
• 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.
• Lead the regulatory team in development of regulatory strategies for 510(k), sBLA and Health Canada submission and approvals.
• Participate and support FDA audits/inspections to maintain all necessary certifications/approvals and ensure compliance with applicable regulations.
• 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.
• Responsible for assuring compliance with all relevant laws and regulations, domestic and international.

What will you need to be successful?

• Minimum Bachelor's degree in Sciences, Engineering or equivalent.
• A minimum of ten years' regulatory experience required.
• 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.

Benefits and Compensation

• 401k Matching Program
• 401k Plus Program
• Discounted Stock Options
• Tuition Reimbursement
• Flexible Personal/Vacation 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)
• Hands-On, Team-Customized, Mentorship
• Discounts on fitness clubs, travel and more!

Smith+Naphew 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.

Inclusion + Belonging: Committed to Welcoming, Celebrating and Thriving. Learn more about our Employee Inclusion Groups on our website https://www.smith-nephew.com/

Stay connected by joining our Talent Community. We're more than just a company - we're a community! Follow us on LinkedIn to see how we support and empower our employees and patients every day. Check us out on Glassdoor for a glimpse behind the scenes and a sneak peek into You. Unlimited., life, culture, and benefits at S+N. Explore our website and learn more about our mission, our team, and the opportunities we offer. Smith+Naphew is a global medical technology company. We design and manufacture technology that takes the limits off living. We support healthcare professionals to return their patients to health and mobility, helping them to perform at their fullest potential. From our first employee and founder, T.J. Smith, to our team today, it’s our people who make Smith+Naphew a unique place. Yes, we love to innovate and develop exciting technologies, and we offer competitive salaries and progressive benefits. But it’s our culture - of Care, Collaboration and Courage - that really sets us apart. Through a spirit of ownership and can-do attitude we work together to win. We’re a company of people who care about each other, about our customers and their patients, and about our communities. Together, we fulfill our shared purpose of Life Unlimited.