Regulatory Affairs Specialist II – Heart Failure (on-site)

Are you passionate about making a difference in the lives of patients with heart failure? Do you have a strong understanding of regulatory affairs and a desire to work on-site with a leading medical device company? If so, we have an exciting opportunity for you as a Regulatory Affairs Specialist II for our Heart Failure division at Abbott. In this role, you will be responsible for navigating the complex world of regulatory requirements to ensure our products are in compliance and accessible to patients in need. We are looking for an experienced and driven individual with a strong attention to detail and a commitment to improving patient outcomes. If you are ready to use your skills and expertise to make a positive impact, we encourage you to apply for this position.

1. Develop and maintain a deep understanding of regulatory requirements for medical devices in the heart failure space.
2. Collaborate with cross-functional teams to ensure compliance with all relevant regulations and standards.
3. Conduct regulatory assessments and gap analyses to identify potential compliance issues and develop solutions.
4. Prepare and submit regulatory submissions, such as 510(k)s, PMAs, and CE Mark applications.
5. Communicate with regulatory agencies and participate in meetings and audits as needed.
6. Monitor changes in regulations and provide updates to internal stakeholders.
7. Support the development and maintenance of product labeling and promotional materials to ensure compliance.
8. Review and approve product changes to ensure compliance with regulatory requirements.
9. Provide guidance and training to other team members on regulatory processes and requirements.
10. Participate in post-market surveillance activities, including adverse event reporting.
11. Develop and maintain relationships with key stakeholders, including regulatory agencies and industry associations.
12. Stay up-to-date on industry trends and best practices in regulatory affairs.
13. Assist with the preparation and execution of regulatory strategies for new product development and market expansion.
14. Ensure timely and accurate completion of all regulatory deliverables.
15. Support quality management and risk management activities to maintain compliance.
16. Proactively identify and address potential compliance issues.
17. Maintain accurate and up-to-date records and documentation.
18. Participate in continuous improvement initiatives to enhance regulatory processes and procedures.
19. Adhere to all company policies, procedures, and guidelines.
20. Continuously strive to improve patient outcomes through compliance with regulations and standards.

According to JobzMall, the average salary range for a Regulatory Affairs Specialist II – Heart Failure (on-site) in Atlanta, GA, USA is $70,000-$90,000 per year. This range may vary depending on the specific company, experience level, and responsibilities of the individual in the role.

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.