Columbia, Maryland, United States · Hybrid
$102k–$152k/yr
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 desig…
Skills: Regulatory Strategy, FDA 510(k) Submissions, HCT/P Compliance, Combination Products, FDA Pre-submissions
Netherlands · Hybrid
$65k–$98k/yr
North West Netherlands Life. Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. Are you a commercially driven sales professional who thrives in the operating theatre environ…
Skills: Field Sales, Stakeholder Management, Operating Theatre Support, Clinical Credibility, Account Planning
France · Hybrid
$41k–$65k/yr
Life Unlimited (Une vie sans limites). Chez S+N, nous créons et manufacturons des technologies qui repoussent les limites de la vie. Vous êtes un professionnel de la vente motivé, prêt à avoir un impact concret dans le s…
Skills: Sales Development, Hospital Relationship Management, Tender Management, Clinical Needs Analysis, Strategic Planning
Mumbai City, Maharashtra, India · Hybrid
Medical Education Meeting Planner – Mumbai, India Life Unlimited. At Smith+Nephew, we design and manufacture technology that takes the limits off living! What will you be doing? Medical Education Meeting Planner is Respo…
Skills: Meeting Planning, Event Management, Budget Management, Vendor Negotiation, Compliance Reporting
Fort Lauderdale, Florida, United States · On-site
Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. As a Sports Medicine Territory Manager, you will be a product consultant in the Sports Medicine product portfolio spe…
Skills: Medical Device Sales, Clinical Case Coverage, Territory Management, Surgeon Training, Relationship Building
Wrocław, Lower Silesian Voivodeship, Poland · Hybrid
$176k–$263k/yr
Job Advert Life. Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. Are you ready to take ownership of complex IT programmes and drive meaningful change across an internatio…
Skills: IT Project Management, Network Infrastructure, Agile, Scrum, Prince2
Wrocław, Lower Silesian Voivodeship, Poland · Hybrid
$160k–$239k/yr
Life. Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. Are you ready to take ownership of complex network environments and shape the future of enterprise connectivity? As …
Skills: Network Design, LAN, WAN, Wireless Technologies, Technical Documentation
Mansfield, Massachusetts, United States · Hybrid
$97k–$145k/yr
Senior Design Quality Engineer (Mansfield, MA) Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. Do you want to work in a collaborative environment that promotes innov…
Skills: Design Controls, Risk Management, FMEA, Test Method Validation, Measurement Systems Analysis
Calgary, Alberta, Canada · On-site
Associate Account Manager, Sports Medicine (Calgary, Alberta, Canada) Life Unlimited. At Smith+Nephew, we design and manufacture technology that takes the limits off living. As an Associate Account Manager, you will be a…
Skills: Account Management, Sales Strategy, Business Forecasting, Market Analysis, CRM Tools
Mississauga, Ontario, Canada · On-site
$41k–$61k/yr
Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. The Logistics Associate is an on-site member of the Logistics Team located in a Local Distribution Center (LDC) or an…
Skills: Order Picking, Packing, Shipping, Inventory Management, Quality Inspection
Nagoya, Japan · On-site
スミス・アンド・ネフューはグローバルに展開するメディカルカンパニーです。 怪我や病気で健康を損なわれた患者様の生活の質を取り戻すため、日々努力を続けている医療従事者の皆様を自社の製品やサービスを通じサポートしています。 オーソぺディックス事業部（Orthopaedics Division）は、整形外科領域における関節置換術（人工関節）や外傷治療（トラウマ）などに対応する製品とソリューションを提供する部門です。最新のロボティクス技術と低侵…
Skills: Sales Strategy, Account Management, Medical Device Sales, Relationship Building, Budget Management
Barcelona, Catalonia, Spain · On-site
$26k–$38k/yr
Life. Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. Da el siguiente paso en tu carrera en un entorno donde la precisión, la organización y el trabajo en equipo son clav…
Skills: Warehouse Operations, Order Preparation, Stock Control, Inventory Traceability, MS Office
France · Hybrid
$41k–$65k/yr
Secteur : Sud-Ouest Atlantique Départements : 17, 16, 33, 24, 40, 47, 64, 32, 65, 46, 82, 31 Life Unlimited (Une vie sans limites). Chez S+N, nous créons et manufacturons des technologies qui repoussent les limites de la…
Skills: Strategic Sales, Medical Device Sales, Orthopedic Surgery Knowledge, CRM Proficiency, Negotiation
Warsaw, Masovian Voivodeship, Poland · Hybrid
$228k–$342k/yr
Life. Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. Are you ready to shape the future of Service as a true growth engine across a diverse and fast evolving region? As S…
Skills: Strategic Thinking, Commercial Acumen, Stakeholder Management, Data Analysis, Service Revenue Growth
Maple Plain, Minnesota, United States · Hybrid
$65k–$98k/yr
Life. Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. Integrity Orthopaedics (now part of Smith + Nephew) is a medical device company transforming soft tissue repair with…
Skills: Manufacturing Process Development, Process Validation, CAD, SolidWorks, Root Cause Analysis
Coimbra, Portugal · On-site
Life. Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. We are currently looking for a R&D Software Test Engineer in the Sports Medicine business to drive Systems and Softw…
Skills: Testing, Medical Technology, Innovation
Tampa, Florida, United States · On-site
Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. The Mobile Field Logistics Specialist is an on-site member of the Logistics Team in a District Sales Office. This per…
Skills: Logistics, Customer Service, Inventory Management, Communication, Problem Solving
France · Hybrid
$44k–$65k/yr
Life Unlimited (Une vie sans limites). Chez S+N, nous créons et manufacturons des technologies qui repoussent les limites de la vie. Vous êtes un professionnel de la vente motivé, prêt à avoir un impact concret dans le s…
Skills: Sales Development, Medical Device Sales, Hospital Relationship Management, Tender Management, Clinical Needs Analysis
Netherlands · Hybrid
$51k–$82k/yr
Life. Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. Are you a driven sales professional looking to make a real difference in healthcare? This is your opportunity to own…
Skills: Medical Device Sales, Pharmaceutical Sales, Account Planning, Clinical Training, Relationship Management
Lyon, Auvergne-Rhône-Alpes, France · Hybrid
$41k–$65k/yr
Life Unlimited (Une vie sans limites). Chez S+N, nous créons et manufacturons des technologies qui repoussent les limites de la vie. Vous êtes un professionnel de la vente motivé, prêt à avoir un impact concret dans le s…
Skills: Sales Development, Medical Device Sales, Hospital Relationship Management, Tender Management, Clinical Needs Analysis
Columbia, Maryland, United States • Hybrid
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The role involves leading regulatory strategies and submissions for HCT/P and device-led combination products. Key duties include reviewing promotional materials, managing change controls, and supporting FDA audits to ensure full compliance.
Candidates need a bachelor's degree in a scientific discipline and at least 5 years of regulatory affairs experience. Proven expertise in FDA 510(k) submissions and knowledge of 21 CFR 1271 are highly desired.
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.
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.
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.
We anticipate the application window for this opening to close on 08.07.2026
**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.
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.
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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. Please note: not all products referred to may be approved for use or available in all markets.
Offices: 5 Hatters Lane, Watford, Hertfordshire WD18 8YE, GB · Oberneuhofstrasse 10d, Baar, ZG 6340, CH · 150 Minuteman Rd, Andover, MA 01810, US · Marii Curie-Skłodowskiej 12, Wrocław, Dolnośląskie 50-381, PL · 101 Hessle Road, Hull, England HU3 2AH, GB
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. Please note: not all products referred to may be approved for use or available in all markets.
Offices: 5 Hatters Lane, Watford, Hertfordshire WD18 8YE, GB · Oberneuhofstrasse 10d, Baar, ZG 6340, CH · 150 Minuteman Rd, Andover, MA 01810, US · Marii Curie-Skłodowskiej 12, Wrocław, Dolnośląskie 50-381, PL · 101 Hessle Road, Hull, England HU3 2AH, GB
