We are seeking a highly motivated and dedicated individual to join our team at Stryker as a Staff Regulatory Affairs Specialist. This is a unique opportunity to make a meaningful impact on the healthcare industry by ensuring compliance and regulatory adherence for our innovative medical devices. As a member of our team, you will play a crucial role in bringing life-changing products to market and ensuring patient safety. We are looking for candidates with a strong understanding of regulatory affairs, impeccable attention to detail, and a passion for making a difference in the lives of others. If you are driven, detail-oriented, and have a desire to work for a company that is dedicated to improving patient outcomes, we encourage you to apply for this position.
- Ensure compliance with all relevant regulations and standards for medical devices.
- Develop and maintain regulatory strategies for new and existing products.
- Prepare and submit regulatory submissions to obtain necessary approvals for product launch.
- Monitor and interpret changes in regulatory requirements and communicate updates to relevant stakeholders.
- Collaborate with cross-functional teams to ensure timely and successful completion of regulatory projects.
- Review and approve product labeling and marketing materials for regulatory compliance.
- Maintain accurate and up-to-date regulatory documentation and records.
- Participate in internal and external audits and inspections.
- Provide regulatory guidance and support to other departments as needed.
- Stay current on industry trends and developments in regulatory affairs.
- Conduct risk assessments and develop risk mitigation strategies.
- Represent the company during interactions with regulatory authorities.
- Ensure timely resolution of any regulatory issues or deficiencies.
- Contribute to continuous improvement efforts in regulatory processes and systems.
- Uphold the company's commitment to patient safety and product quality through adherence to regulatory requirements.
Bachelor's Degree In A Relevant Field Such As Biology, Chemistry, Or Engineering.
Minimum Of 3 Years Of Experience In Regulatory Affairs Within The Medical Device Industry.
In-Depth Knowledge Of Fda Regulations And International Regulatory Requirements.
Strong Understanding Of Quality Management Systems, Including Iso 13485 And 21 Cfr Part 820.
Excellent Communication And Project Management Skills, With The Ability To Work Effectively In A Cross-Functional Team Environment.
Quality Assurance
Project Management
Clinical Research
Risk assessment
Regulatory compliance
FDA regulations
Medical Devices
Change
Product Registration
Regulatory Submissions
Labeling Requirements
International Standards
Communication
Conflict Resolution
Leadership
Time management
flexibility
Critical thinking
Attention to detail
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Staff Regulatory Affairs Specialist is $70,000-$120,000 per year. This can vary depending on factors such as location, experience, and the specific industry or company the specialist is working for.
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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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