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Posted May 12Senior Regulatory Affairs Specialist (Columbia, MD)
United StatesHybrid
Responsibilities
- Act as NPD regulatory lead on new device-biologics combination products and define regulatory strategy for FDA submissions including authoring FDA 510(k) submissions and FDA pre-submissions.
- Participate and support FDA audits/inspections to maintain all necessary certifications/approvals and ensure compliance with applicable regulations.
Requirements
- What will you need to be successful? Bachelor’s degree in Chemistry, Biology, or a related scientific discipline.
- Regulatory Affairs Certification (RAC Devices) preferred.
- experience in Regulatory Affairs. Proven
- experience supporting and/or leading FDA 510(k) submissions and Pre‑Sub meetings (Q‑Subs).
- Experience and working knowledge of HCT/Ps (21 CFR 1271) highly desired. Demonstrated
- experience liaising directly with the FDA, including serving as the regulatory lead in Agency interactions for Pre‑Subs and 510(k) submissions.
- Ability to work strategically within complex, business‑critical, and high‑visibility programs.
- Strong strategic and critical‑thinking skills, with the ability to proactively identify and evaluate regulatory risks.
- Demonstrated initiative, strong work ethic, and excellent oral and written communication skills, with the ability to influence cross‑functional partners effectively.
Benefits
- We anticipate the application window for this opening to close on 05.22.2026 **This position does not offe r visa sponsorship now or in the future
- The anticipated base compensation range for this position is $101,500.00 to $152,250.00 USD annually.
- The actual base pay offered to the successful candidate will be based on multiple factors, including but not limited to job-related knowledge/skills, experience, and geographic location.
- Compensation decisions are dependent upon the facts and circumstances of each position and candidate.
- In addition to base pay, we offer competitive bonus and benefits, including medical, dental, and vision coverage, 401(k), tuition reimbursement, medical leave programs, parental leave, generous PTO, paid company holidays, 8 hours of volunteer time annually, and a variety of wellness offerings such as EAP. You Unlimited.
- Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement Work/Life Balance: Flexible Personal/Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service Day Your Wellbeing: Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program Training: Hands-On, Team-Customized, Mentorship Extra Perks: Discounts on fitness clubs, travel and
Contact
- Inclusion and Belonging- Committed to Welcoming, Celebrating and Thriving on Inclusion and Belonging, Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/).
Additional details
- At Smith+Nephew we design and manufacture technology that takes the limits off living.
- The Senior Regulatory Affairs Specialist will be responsible for projects by leading regulatory submissions and designing comprehensive regulatory strategies on Human Cells, Tissues, and Cellular and Tissue-Based products (HCT/P) projects as well as define regulatory strategies for new device-led combination products.
- Reviews and approves advertising/promotional materials, provides regulatory input into change controls and CAPAs and support audits/inspections to ensure full compliance for US S+N site.
- What will you be doing? Act as regulatory lead on new HCT/P projects, define regulatory strategy and support project deliverables.
- Assesses the regulatory impact of changes in HCT/P product specifications, manufacturing process, labeling, and other changes to ensure compliance with FDA 21 CFR 1271 requirements.
- Reviews and approves advertising and promotional materials for HCT/Ps.
- Work collaboratively with cross-functional teams (i.e.
- Marketing, Legal, Compliance, R&D) to develop and review materials which are compliant with applicable regulations, guidelines, corporate policies and product development objectives.
- 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 represents Business RA with excellence in interactions with regional RA representatives.