Regulatory Affairs Specialist

Are you passionate about making a difference in the healthcare industry? Do you have a keen eye for detail and a strong understanding of regulatory guidelines? Look no further, Loma Linda University is seeking a highly motivated Regulatory Affairs Specialist to join our team. As a specialist in this role, you will play a crucial role in ensuring compliance with all relevant regulations and policies to support our mission of providing exceptional patient care. We are looking for an individual with a strong background in regulatory affairs, exceptional communication skills, and a dedication to promoting ethical and compliant practices. If you are ready to take on this exciting and impactful role, we encourage you to apply now!

1. Develop and implement strategies to ensure compliance with all relevant regulations and policies within the healthcare industry.
2. Stay up-to-date on regulatory changes and communicate updates to relevant team members.
3. Conduct thorough research and analysis to ensure all processes and procedures are in line with regulatory guidelines.
4. Collaborate with various departments, including legal and clinical teams, to ensure compliance with regulations.
5. Review and approve all regulatory submissions, including applications, reports, and documentation.
6. Conduct internal audits to identify potential compliance issues and develop corrective action plans.
7. Communicate with external regulatory agencies and serve as the primary point of contact for all regulatory inquiries.
8. Develop and implement training programs to educate team members on regulatory compliance.
9. Monitor and track all regulatory submissions, ensuring timely and accurate completion.
10. Maintain accurate records and documentation of all regulatory activities.
11. Identify and escalate any potential compliance risks or issues to management.
12. Act as a liaison between the organization and regulatory agencies during inspections or audits.
13. Assist in the development and implementation of policies and procedures to promote ethical and compliant practices.
14. Attend conferences and workshops to stay current on industry trends and best practices.
15. Collaborate with cross-functional teams to ensure compliance with all regulatory requirements for new products or services.
16. Proactively identify areas for process improvement and implement necessary changes to enhance compliance.
17. Maintain confidentiality and adhere to ethical standards in all regulatory activities.
18. Represent the organization in a professional manner and promote a positive image of the company to regulatory agencies and the public.
19. Uphold the mission and values of Loma Linda University in all aspects of the role.
20. Other duties as assigned by management.

According to JobzMall, the average salary range for a Regulatory Affairs Specialist in Loma Linda, CA, USA is between $70,000 and $90,000 per year. This may vary depending on the specific company, years of experience, and education level of the individual.

Founded in 1905, Loma Linda University (LLU) is a private, Christian, coeducational, health sciences university located in Southern California 60 miles east of Los Angeles close to San Bernardino. As such it aspires to provide an environment for learning that emphasizes individual commitment to Christ, personal integrity, intellectual development, and community service.