Senior Regulatory Affairs Specialist

At Stryker, we are committed to improving lives through innovative and high-quality medical devices. We are currently seeking a highly skilled and experienced Senior Regulatory Affairs Specialist to join our team. This role is crucial in ensuring our products meet all regulatory requirements and are safe for use by patients and healthcare professionals. If you have a strong background in regulatory affairs and a passion for making a difference in the healthcare industry, we want to hear from you. Join us in our mission to help people live more active and fulfilling lives.

1. Develop and maintain a thorough understanding of all relevant regulatory guidelines and requirements for medical devices.
2. Collaborate with cross-functional teams to ensure that all new and existing products meet regulatory standards and requirements.
3. Prepare and submit regulatory submissions, including 510(k) and premarket approval applications, to the appropriate regulatory agencies.
4. Monitor and track the status of regulatory submissions and communicate updates to stakeholders.
5. Keep abreast of changes in regulations and communicate impact to the organization.
6. Provide regulatory guidance and support to product development teams, ensuring compliance with all applicable regulations and standards.
7. Develop and maintain relationships with regulatory agencies to facilitate efficient and timely approvals.
8. Participate in audits and inspections by regulatory agencies and provide necessary support and documentation.
9. Conduct regulatory reviews of product labeling, packaging, and promotional materials to ensure compliance.
10. Maintain all regulatory documentation and records in accordance with company policies and procedures.
11. Continuously monitor and assess potential regulatory risks and provide recommendations for risk mitigation.
12. Train and mentor junior regulatory affairs team members.
13. Represent the company and its products at industry conferences, meetings, and other events related to regulatory affairs.
14. Continuously seek opportunities for process improvement and implement best practices to ensure compliance and efficiency.

According to JobzMall, the average salary range for a Senior Regulatory Affairs Specialist in Dallas, TX, USA is $83,000 - $120,000 per year. This can vary depending on factors such as experience, education, and the specific industry of the company.

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.