Senior Regulatory Affairs Specialist
Are you a highly motivated and experienced regulatory affairs professional looking for a new challenge? Look no further! Stryker is seeking a Senior Regulatory Affairs Specialist to join our dynamic team. As a global leader in the medical technology industry, Stryker is committed to improving healthcare through innovative products and solutions. In this role, you will have the opportunity to make a significant impact by ensuring our products meet regulatory requirements in markets around the world. We are looking for a detail-oriented and proactive individual with a strong understanding of regulatory guidelines and experience in product registration and submissions. If you are ready to take your career to the next level and be a part of a company that is changing lives, apply now for the Senior Regulatory Affairs Specialist position at Stryker.
- Develop and implement regulatory strategies to ensure compliance with global regulations and standards for medical devices.
- Prepare and submit product registrations and regulatory submissions, including 510(k)s, PMAs, and CE Mark applications, in a timely and efficient manner.
- Act as the main point of contact with regulatory agencies and notified bodies, responding to inquiries and providing necessary documentation.
- Conduct thorough reviews of product labeling, advertising, and promotional materials to ensure compliance with regulatory requirements.
- Monitor and track changes in regulations and standards, communicating updates and implications to cross-functional teams.
- Collaborate with cross-functional teams, including R&D, quality, and clinical teams, to ensure regulatory requirements are met throughout the product development process.
- Support internal and external audits, providing necessary documentation and guidance to ensure compliance with regulatory requirements.
- Maintain and update regulatory files and databases to ensure accurate and up-to-date information is readily accessible.
- Participate in regulatory and industry conferences and forums to stay current on regulatory trends and requirements.
- Mentor and train junior regulatory affairs team members to ensure a high level of expertise and knowledge within the department.
- Continuously evaluate and improve regulatory processes and procedures to increase efficiency and compliance.
- Represent Stryker in a professional and ethical manner, promoting the company's mission and values to external stakeholders.
Bachelor's Degree In A Scientific Or Health-Related Field: A Senior Regulatory Affairs Specialist At Stryker Should Possess A Strong Educational Background In A Relevant Field Such As Biology, Chemistry, Or Healthcare. This Knowledge Is Essential In Understanding And Interpreting Complex Regulatory Requirements.
Minimum Of 5 Years Of Experience In Regulatory Affairs: Stryker Requires A Minimum Of 5 Years Of Experience In A Regulatory Affairs Role, Preferably In The Medical Device Industry. This Ensures That The Candidate Has A Thorough Understanding Of The Regulatory Landscape And Can Effectively Navigate The Complex Regulatory Processes.
In-Depth Knowledge Of Fda Regulations And Guidelines: The Ideal Candidate Should Have A Comprehensive Understanding Of Fda Regulations And Guidelines, Including 21 Cfr Part 820, 21 Cfr Part 801, And 21 Cfr Part 803. This Knowledge Is Crucial In Ensuring Compliance With Regulatory Requirements And Obtaining Timely Approvals.
Strong Communication And Interpersonal Skills: As A Senior Regulatory Affairs Specialist, The Candidate Will Be Required To Interact With Multiple Internal And External Stakeholders, Including Regulatory Agencies. Excellent Communication And Interpersonal Skills Are Essential For Effective Communication And Collaboration.
Attention To Detail And Strong Analytical Skills: The Regulatory Landscape Is Constantly Evolving, And A Senior Regulatory Affairs Specialist Must Be Able To Keep Up With The Changes. This Requires Strong Analytical Skills And Attention To Detail To Review And Interpret Complex Regulatory Documents And Identify Potential Issues Or Risks.
Risk Management
Quality Assurance
Technical Writing
Regulatory compliance
FDA regulations
Product Registration
Clinical Evaluations
Labeling Requirements
Global Submissions
Post-Market Surveillance
Cross-
Communication
Conflict Resolution
Leadership
Time management
creativity
flexibility
Teamwork
Adaptability
Problem-Solving
Empathy
According to JobzMall, the average salary range for a Senior Regulatory Affairs Specialist in Denver, CO, USA is $85,000 - $120,000 per year. However, this can vary depending on factors such as the specific company, years of experience, and education level.
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Stryker Corp. is engaged in providing medical technology products and services. It operates through the following segments: Orthopaedics, MedSurg and Neurotechnology and Spine. The Orthopaedics segment provides reconstructive and trauma implant systems. The Medsurg segment deals with surgical instruments and equipment, endoscopy, patient handling, and reprocessed medical devices. The Neurotechnology and Spine segment pertains to spinal implants and neurovascular products.
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