Smith & Nephew

Senior Regulatory Affairs Specialist

Smith & Nephew$101K — $152K *
Healthcare
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in a scientific or technical discipline or equivalent experience
  • Minimum of 5 years in Regulatory Affairs or related field in the medical device industry
  • In-depth knowledge of global regulatory requirements and medical products
  • Experience managing regulatory submissions and working with health authorities
  • Strong analytical, problem solving, and project management capabilities
  • Excellent written and verbal communication skills
  • RAPS Certification is an advantage.

Responsibilities

  • Develop and implement regulatory strategies for global product clearances and approvals
  • Provide regulatory guidance throughout the product lifecycle
  • Prepare and manage submissions to global health authorities
  • Evaluate product changes for regulatory impact and compliance
  • Establish and nurture relationships with regulatory agencies
  • Support audits and contribute to compliance initiatives
  • Mentor colleagues and maintain regulatory procedures
  • Manage regulatory databases and assist with special projects.

Benefits

  • 401k Matching Program and Plus Program
  • Tuition reimbursement for further education
  • Flexible personal and vacation time off
  • Paid holidays and community service day
  • Comprehensive medical, dental, and vision coverage
  • Health savings account with employer contributions
  • Parental leave and fertility assistance programs
  • Employee assistance program
  • Discounts on fitness clubs and travel
Full Job Description
**This position does not offer visa sponsorship now or in the future**

What will you be doing?
  • Develop and execute regulatory strategies to support global product registrations, clearances, and approvals.
  • Provide regulatory guidance to product development and manufacturing teams throughout the product lifecycle.
  • Prepare, coordinate, and manage regulatory submissions to global health authorities.
  • Assess product and manufacturing changes for regulatory impact and continued compliance with global requirements.
  • Build and maintain strong relationships with regulatory agencies through effective written and verbal communication.
  • Support internal and external audits and contribute to regulatory intelligence and compliance initiatives.
  • Develop and maintain regulatory procedures and provide mentorship and training to colleagues and cross functional partners.
  • Maintain regulatory databases and support additional regulatory projects as assigned.


What will you need to be successful?
  • Bachelor's degree or equivalent work experience, preferably in a scientific or technical discipline.
  • 5+ years of Regulatory Affairs experience or related experience within the medical device or healthcare industry.
  • Strong knowledge of global regulatory requirements, medical products, product development processes, and design controls.
  • Proven experience managing regulatory submission activities and working with regulatory agencies.
  • Excellent analytical, problem solving, technical writing, communication, and project management skills.
  • Ability to effectively manage multiple priorities while collaborating across diverse teams.
  • RAPS Certification is a plus.


We anticipate the application window for this opening to close on 09.17.2026

The anticipated base compensation range for this position is $101,500.00 - $152,250.00 USD annually and the compensation offered will depend on the candidate's qualifications, job-related knowledge/skills, geographical location. You will be entitled to receive bonus and benefits, which include medical, dental, and vision coverage, 401k, tuition reimbursement, medical leave programs, and a variety of wellness offerings.

Smith & Nephew follows the Pay Transparency and non-discrimination provisions described by local and state policies.

  • 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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About Smith & Nephew

Smith & Nephew is a global medical technology company headquartered in London, England. The company designs, manufactures, and sells medical devices and products for orthopedic reconstruction, sports medicine, and trauma. Smith & Nephew operates in more than 100 countries and employs over 17,500 people worldwide. The company was founded in 1856 by Thomas James Smith and his nephew, Horatio Nelson Smith, and has grown through a series of mergers and acquisitions. Smith & Nephew's products include joint replacement systems, wound care products, and surgical instruments. The company is listed on the London Stock Exchange and is a constituent of the FTSE 100 Index.
Learn more about Smith & Nephew
Size
17,500 employees
Market Cap
$11.5 billion
Industry
Net Income
$448 million
5 Year Trend
+2.2%
Revenue
$4.5 billion

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