Senior Regulatory Affairs Specialist

Are you a seasoned Regulatory Affairs professional looking for your next challenge? Do you have a strong background in navigating complex regulatory landscapes and ensuring compliance with global regulations? If so, we have an exciting opportunity for you at Abbott as a Senior Regulatory Affairs Specialist.As a Senior Regulatory Affairs Specialist, you will play a crucial role in ensuring that our products meet regulatory requirements and are safe for use by our customers. You will work closely with cross-functional teams, including R&D, marketing, and quality assurance, to develop and implement regulatory strategies for our products. Your expertise in interpreting and applying regulations will be critical in obtaining and maintaining product approvals and clearances.To excel in this role, you must have a minimum of 5 years of experience in regulatory affairs within the medical device or pharmaceutical industry. You should also have a Bachelor's degree in a related field and a strong understanding of global regulations and guidelines. Excellent communication and project management skills are essential for success in this position.If you are passionate about making a difference in the healthcare industry and have a drive for excellence, we encourage you to apply for this role and become a part of our dynamic team at Abbott.

1. Develop and implement regulatory strategies for new and existing products to ensure compliance with global regulations and guidelines.
2. Collaborate with cross-functional teams, including R&D, marketing, and quality assurance, to gather necessary information and documentation for regulatory submissions.
3. Utilize expertise in regulatory affairs to interpret and apply regulations to product development and approval processes.
4. Conduct thorough research and analysis of regulatory requirements and changes to ensure that products meet all necessary standards.
5. Prepare and submit regulatory filings, including 510(k)s, PMAs, and other required documents, to obtain and maintain product approvals and clearances.
6. Monitor and track the progress of regulatory submissions and communicate updates to relevant stakeholders.
7. Stay up-to-date on changes in regulations and guidelines and provide guidance to teams on how to ensure compliance.
8. Provide support for regulatory inspections and audits, including preparing documentation and responding to inquiries.
9. Act as a liaison with regulatory agencies, such as the FDA, to address any questions or concerns related to product submissions.
10. Train and educate team members on regulatory requirements and processes to ensure understanding and compliance.
11. Conduct risk assessments and develop risk mitigation strategies to ensure regulatory compliance and product safety.
12. Collaborate with international teams to ensure that products meet regulatory requirements in other countries.
13. Maintain accurate and organized regulatory records, including submissions, approvals, and correspondence with regulatory agencies.
14. Assist in the development and implementation of company-wide policies and procedures related to regulatory affairs.
15. Act as a subject matter expert on regulatory affairs and provide guidance to other team members as needed.

According to JobzMall, the average salary range for a Senior Regulatory Affairs Specialist in Santa Clara, CA, USA is between $125,000 and $150,000 per year. However, this can vary based on factors such as the specific company, years of experience, and education level. It is important to research the specific company and their salary ranges to get a more accurate estimate.

From removing the regular pain of finger sticks as people manage their diabetes to connecting patients to doctors with real-time information monitoring their hearts, from easing chronic pain and movement disorders to testing half the world’s blood donations to ensure a healthy supply, our purpose is to make the world a better place by bringing life-changing health technologies to the people who need them. That’s our commitment to helping you live your best life.