Senior Regulatory Affairs Specialist (Columbia, MD)

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 handson experience in Regulatory Affairs.

• Proven experience supporting and/or leading FDA 510(k) submissions and PreSub meetings (QSubs).

• 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 PreSubs and 510(k) submissions.

• Deep regulatory expertise within relevant therapy areas, including HCT/Ps and deviceled combination products.

• Ability to work strategically within complex, businesscritical, and highvisibility programs.

• Strong strategic and criticalthinking 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 crossfunctional 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!

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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.