
Director Regulatory Affairs
Welcome to Abbott, a global healthcare company dedicated to creating innovative solutions that help people live healthier lives. We are currently seeking a highly motivated and experienced Director of Regulatory Affairs to join our team. As a Director Regulatory Affairs at Abbott, you will have the opportunity to lead a team in developing and executing regulatory strategies for our products, ensuring compliance with all relevant laws and regulations. We are looking for someone with a strong background in regulatory affairs, excellent leadership skills, and a passion for making a difference in the lives of patients. If you are ready to take on a challenging and rewarding role in a dynamic and fast-paced environment, we encourage you to apply for this position.
- Develop and execute regulatory strategies for all products within Abbott, ensuring compliance with all relevant laws and regulations.
- Lead and manage a team of regulatory professionals, providing guidance and support in their daily activities.
- Stay up-to-date on all changes and updates in regulatory laws and guidelines, and communicate any potential impact to the company.
- Oversee the preparation and submission of regulatory documents to relevant authorities.
- Collaborate with cross-functional teams, including R&D, marketing, and legal, to ensure timely and accurate completion of regulatory submissions.
- Act as the primary point of contact for all regulatory inquiries and audits.
- Monitor and assess the regulatory landscape, identifying potential risks and proposing mitigation strategies.
- Develop and maintain relationships with regulatory authorities and industry organizations.
- Participate in and lead meetings with internal and external stakeholders to provide regulatory updates and guidance.
- Train and educate employees on regulatory requirements and best practices.
- Lead the development and implementation of processes and procedures to ensure compliance with regulatory requirements.
- Conduct internal audits to ensure adherence to regulatory standards and identify areas for improvement.
- Collaborate with the quality assurance team to ensure regulatory compliance throughout the product lifecycle.
- Represent Abbott in industry conferences and events related to regulatory affairs.
- Uphold Abbott's commitment to creating innovative solutions that improve the health of patients worldwide.
Bachelor's Or Advanced Degree In A Relevant Scientific Field (E.g. Biology, Chemistry, Pharmaceutical Sciences)
Minimum Of 10 Years Experience In Regulatory Affairs, Preferably In The Healthcare Or Pharmaceutical Industry
In-Depth Knowledge Of Fda Regulations And Guidelines, As Well As Global Regulatory Requirements
Proven Track Record Of Successfully Leading Regulatory Submissions And Approvals For Medical Devices Or Pharmaceutical Products
Excellent Communication And Leadership Skills, With The Ability To Effectively Collaborate With Cross-Functional Teams And Regulatory Authorities.
Quality Assurance
Strategic Planning
Communication Skills
Project Management
Global regulations
Team Leadership
Compliance Management
Risk assessment
Labeling
Regulatory Strategy
Regulatory Intelligence
Submission Preparation
Communication
Conflict Resolution
Leadership
Time management
Interpersonal Skills
creativity
Attention to detail
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Director Regulatory Affairs in Green Oaks, IL, USA is between $100,000 and $160,000 per year. This can vary depending on factors such as experience, company size, and industry. Directors with more experience and in larger companies may earn towards the higher end of this range.
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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.

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