RA Manager

Welcome to Abbott! We are a global healthcare company dedicated to improving the lives of people around the world. We are currently seeking a highly motivated and experienced RA Manager to join our team. As an RA Manager, you will play a crucial role in ensuring our products comply with all regulatory requirements and are safe for use by our patients. We are looking for someone who is passionate about making a positive impact in the healthcare industry and has a strong background in regulatory affairs. If you are a detail-oriented and driven individual with excellent leadership skills, we encourage you to apply for this exciting opportunity.

1. Develop and implement regulatory strategies to ensure compliance with all relevant laws, regulations, and guidelines.
2. Stay up-to-date with industry trends, changes in regulations, and best practices to proactively identify potential compliance issues and provide solutions.
3. Collaborate with cross-functional teams to ensure that new products and changes to existing products are in compliance with regulatory requirements.
4. Prepare and submit regulatory submissions, including 510(k) applications, pre-market notifications, and post-market reports.
5. Serve as the primary point of contact for all regulatory agencies, responding to inquiries, providing requested information, and participating in audits and inspections.
6. Develop and maintain strong relationships with regulatory agencies and key stakeholders to ensure a smooth and efficient review process.
7. Lead and manage a team of regulatory affairs professionals, providing guidance, mentorship, and training as needed.
8. Conduct internal audits to ensure compliance with company policies, procedures, and regulatory requirements.
9. Monitor post-market surveillance data and trends, and take appropriate actions to address any potential issues or concerns.
10. Collaborate with other departments, such as R&D, marketing, and quality, to ensure that all regulatory requirements are considered during the development and launch of new products.
11. Act as a subject matter expert on regulatory affairs, providing guidance and support to other teams and departments as needed.
12. Develop and maintain departmental procedures and processes to ensure compliance with all applicable regulations and standards.
13. Participate in industry conferences, workshops, and training programs to stay current on regulatory topics and share knowledge and best practices with the team.
14. Foster a culture of continuous improvement within the regulatory affairs team, identifying opportunities to streamline processes and improve efficiency.

According to JobzMall, the average salary range for a RA Manager in Abbott Park, Green Oaks, IL, USA is $117,000 to $145,000 per year. This can vary depending on factors such as experience, qualifications, and the specific company that the RA Manager is working for. Additionally, location can also play a role in the salary range, as different regions may have different cost of living and pay scales.

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.