Senior Regulatory Affairs Specialist (Columbia, MD)

Smith+Nephew•Columbia, MD

5d•Hybrid

About The Position

Life Unlimited. 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. 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. 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. 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 represents Business RA with excellence in interactions with regional RA representatives. Drafts and maintains applicable policies and procedures supported or owned by the regulatory affairs function. 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. Performs other duties as assigned. What will you need to be successful? Bachelor’s degree in Chemistry, Biology, or a related scientific discipline. Regulatory Affairs Certification (RAC Devices) preferred. Minimum of 5 years of hands‑on 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. Deep regulatory expertise within relevant therapy areas, including HCT/Ps and device‑led combination products. 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. This position does not offer 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. We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve. 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/). 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 more! #LI-HYBRID #LI-SB2 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. 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+Nephew 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+Nephew 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.

Requirements

Bachelor’s degree in Chemistry, Biology, or a related scientific discipline.
Minimum of 5 years of hands‑on experience in Regulatory Affairs.
Proven experience supporting and/or leading FDA 510(k) submissions and Pre‑Sub meetings (Q‑Subs).
Demonstrated experience liaising directly with the FDA, including serving as the regulatory lead in Agency interactions for Pre‑Subs and 510(k) submissions.
Deep regulatory expertise within relevant therapy areas, including HCT/Ps and device‑led combination products.
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.

Nice To Haves

Regulatory Affairs Certification (RAC Devices) preferred.
Experience and working knowledge of HCT/Ps (21 CFR 1271) highly desired.

Responsibilities

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.
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.
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.
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 represents Business RA with excellence in interactions with regional RA representatives.
Drafts and maintains applicable policies and procedures supported or owned by the regulatory affairs function.
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.
Performs other duties as assigned.