Senior Regulatory Affairs Specialist (Columbia, MD)

<p><b>Life Unlimited. </b>At Smith&#43;Nephew we design and manufacture technology that takes the limits off living.   </p><p></p><p>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&#43;N site.<br /> </p><p><b>What will you be doing?</b></p><ul><li><p>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.</p></li><li><p>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.</p></li><li><p>Reviews and approves advertising and promotional materials for HCT/Ps. Work collaboratively with cross-functional teams (i.e. Marketing, Legal, Compliance, R&amp;D) to develop and review materials which are compliant with applicable regulations, guidelines, corporate policies and product development objectives.</p></li><li><p>Participate and support FDA audits/inspections to maintain all necessary certifications/approvals and ensure compliance with applicable regulations.</p></li><li><p>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.</p></li><li><p>Drafts and maintains applicable policies and procedures supported or owned by the regulatory affairs function.</p></li><li><p>Stays updated on relevant FDA regulations/guidance’s and provides notice and summary of the impacts of any changes to the regulatory landscape to the business.</p></li><li><p>Performs other duties as assigned.</p></li></ul><p></p><p><b>What will you need to be successful?</b></p><ul><li><p>Bachelor’s degree in Chemistry, Biology, or a related scientific discipline.</p></li><li><p>Regulatory Affairs Certification (RAC Devices) preferred.</p></li><li><p>Minimum of 5 years of hands‑on experience in Regulatory Affairs.</p></li><li><p>Proven experience supporting and/or leading FDA 510(k) submissions and Pre‑Sub meetings (Q‑Subs).</p></li><li><p>Experience and working knowledge of HCT/Ps (21 CFR 1271) highly desired.</p></li><li><p>Demonstrated experience liaising directly with the FDA, including serving as the regulatory lead in Agency interactions for Pre‑Subs and 510(k) submissions.</p></li><li><p>Deep regulatory expertise within relevant therapy areas, including HCT/Ps and device‑led combination products.</p></li><li><p>Ability to work strategically within complex, business‑critical, and high‑visibility programs.</p></li><li><p>Strong strategic and critical‑thinking skills, with the ability to proactively identify and evaluate regulatory risks.</p></li><li><p>Demonstrated initiative, strong work ethic, and excellent oral and written communication skills, with the ability to influence cross‑functional partners effectively.</p></li></ul><p></p><p>**This position <u>does not offe</u>r visa sponsorship now or in the future**</p><p>The anticipated base compensation range for this position is $101,500.00 to $152,250.00 USD annually.</p><p>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.</p><p>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.</p><p></p><p><b>You Unlimited. </b></p><p>We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.    </p><ul><li><p><b>Inclusion and Belonging- </b>Committed to Welcoming, Celebrating and Thriving on Inclusion and Belonging, Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/).</p></li><li><p><b>Your Future:</b> 401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement  </p></li><li><p><b>Work/Life Balance:</b> Flexible Personal/Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service Day  </p></li><li><p><b>Your Wellbeing:</b> Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500&#43; annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program </p></li><li><p><b>Training:</b> Hands-On, Team-Customized, Mentorship  </p></li><li><p><b>Extra Perks:</b> Discounts on fitness clubs, travel and more!  </p></li></ul><p>#LI-HYBRID</p><p>#LI-SB2</p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:left">Smith&#43;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.</p><div><p style="text-align:inherit"></p><p style="text-align:left">Stay connected by joining our <a href="https://smithnephew.wd5.myworkdayjobs.com/External/page/4ba17039009510002b17ea5e89c40000" target="_blank">Talent Community</a>.</p><p style="text-align:inherit"></p><p style="text-align:left"><span><span>We&#39;re</span><span> more than just a company - </span><span>we&#39;re</span><span> a community! Follow us on <a href="https://www.linkedin.com/company/smith-&amp;-nephew/" target="_blank">L</a></span></span><a href="https://www.linkedin.com/company/smith-&amp;-nephew/" target="_blank">inkedIn</a><span><span> to see how we support and empower our employees and patients every day. </span> </span></p></div><div><div><p style="text-align:inherit"></p><p style="text-align:left"><span><span>Check us out on <a href="https://www.glassdoor.com/Overview/Working-at-Smith-and-Nephew-EI_IE10233.11,27.htm" target="_blank">Glassdoor</a> for a glimpse behind the scenes and a sneak peek into </span></span><b><span>You</span><span>. </span><span>Unlimited</span><span>.</span></b><span><span>, life, culture, and benefits at S&#43;N.</span></span></p><p style="text-align:inherit"></p></div><div><p style="text-align:left"><span><span>Explore our <a href="https://www.smith-nephew.com/en/" target="_blank">website</a></span></span><span><span> and learn more about our mission, our team, and the opportunities we offer.</span></span><span> </span></p></div></div><div><p style="text-align:inherit"><span> </span></p></div>