Remote Otter LogoRemoteOtter

Regulatory Affairs Specialist (Orthopaedic Reconstruction) - Remote

Posted 2 days ago

U.S.N

USA - Smith & Nephew

Finance / Legal
Full Time
Worldwide

Share This Job!

Overview

The Regulatory Affairs Specialist will play a vital role in ensuring that Smith+Nephew's Orthopaedic Reconstruction products meet all regulatory requirements for global markets, supporting both US and international regulatory submissions.

In Short

  • Prepare and support regulatory submissions for medical devices.
  • Develop and implement regulatory strategies for timely product launches.
  • Collaborate with project teams to ensure compliance.
  • Manage databases for approved products and UDI systems.
  • Stay updated with regulations and standards.
  • Review engineering changes for compliance.
  • Support international registrations for product portfolios.
  • Use Excel for data analysis related to regulatory activities.
  • Participate in internal and external audits.
  • Work in a hybrid model, balancing remote and on-site responsibilities.

Requirements

  • Bachelor's degree or equivalent in a scientific or technical field.
  • 2-3+ years of experience in Regulatory Affairs.
  • Knowledge of US & EU MDR regulatory requirements.
  • Strong critical thinking and problem-solving skills.
  • Ability to synthesize and implement information effectively.
  • Ethical approach to regulatory compliance.
  • Experience in preparing 510(k), PMA, and MDR submissions.
  • Ability to develop instructions for use (IFU) content.
  • Strong collaboration skills to work with cross-functional teams.
  • Experience in managing regulatory databases.

Benefits

  • Generous annual bonus and pension schemes.
  • Flexible vacation and time off policies.
  • Paid holidays and volunteering hours.
  • Private health and dental plans.
  • Income protection and life assurance.
  • Training and mentorship opportunities.
  • Discounts on gyms and fitness clubs.
  • Salary sacrifice bicycle and car schemes.
  • Employee discounts on various services.
  • Commitment to diversity and inclusion.

Similar Jobs:

M.M

Regulatory Affairs Specialist - Remote

MED Medtronic

5 days ago

Join Medtronic as a Regulatory Affairs Specialist to lead regulatory submissions and enhance healthcare access.

Regulatory Affairs
Medical Devices
Pharmaceutical Sciences
Industrial Engineering
Philippines
Full-time
All others
Natera logo

Regulatory Affairs Specialist - Remote

Natera

3 weeks ago

Join Natera as a Regulatory Affairs Specialist to support women's health and organ health products through regulatory compliance and strategy.

Regulatory Affairs
IN Vitro Diagnostics
CAP
CLIA
USA
Full-time
All others
$87,900 - $109,900 USD/year

Loyal

Regulatory Affairs Specialist - Remote

Loyal

3 weeks ago

Loyal is looking for a Regulatory Affairs Specialist to assist with regulatory submissions and compliance in a clinical-stage veterinary medicine company.

Regulatory Affairs
FDA Regulations
Clinical Trials
Biotech Industry
Worldwide
Full-time
All others
50USD/hour
Alimentiv logo

Regulatory Affairs Specialist - Remote

Alimentiv

11 weeks ago

This position is responsible for managing Global Regulatory Affairs support services related to clinical trials.

Regulatory Affairs
Clinical Trials
Stakeholder Management
Risk Assessment
Germany
Full-time
All others
Alimentiv logo

Regulatory Affairs Specialist - Remote

Alimentiv

11 weeks ago

This position is responsible for managing Global Regulatory Affairs support services related to clinical trials.

Regulatory Affairs
Clinical Trials
Stakeholder Management
Risk Assessment
India
Full-time
All others