Senior Regulatory Affairs Specialist - International

Welcome to Abbott – a global healthcare company that is dedicated to improving people's lives through our innovative and life-changing products. We are currently seeking a highly skilled and experienced Senior Regulatory Affairs Specialist - International to join our dynamic team. As a Senior Regulatory Affairs Specialist, you will play a critical role in ensuring that our products meet all regulatory requirements in the international market. This is a unique opportunity for a driven and detail-oriented individual to make a significant impact in the healthcare industry. If you have a passion for regulatory compliance and a strong understanding of international regulations, we encourage you to apply for this position. Join us at Abbott and be a part of our mission to make a lasting difference in the world of healthcare.

1. Collaborate with cross-functional teams to develop and implement regulatory strategies for international product registrations.
2. Conduct thorough research and stay up-to-date on international regulations for medical devices and pharmaceutical products.
3. Prepare and submit high-quality regulatory submissions for new product registrations, amendments, and renewals.
4. Review and provide input on labeling, advertising, and promotional materials to ensure compliance with international regulations.
5. Serve as the main point of contact for regulatory agencies and communicate effectively to resolve any issues or questions related to submissions.
6. Monitor and track regulatory submissions and approval timelines to ensure timely market access for products.
7. Conduct internal audits to ensure compliance with international regulations and company policies.
8. Develop and maintain relationships with key stakeholders, both internal and external, to ensure effective communication and collaboration.
9. Provide regulatory guidance and support to product development teams, including reviewing and approving design and development plans.
10. Identify potential regulatory risks and provide recommendations for risk mitigation strategies.
11. Participate in regulatory authority inspections and ensure timely and appropriate responses to any observations or findings.
12. Keep accurate and organized records of regulatory submissions, approvals, and correspondence with regulatory agencies.
13. Stay current with industry trends and changes in international regulations that may impact product registrations.
14. Mentor and train junior regulatory affairs team members to ensure compliance with international regulations and company standards.
15. Represent the company at industry conferences and meetings to share knowledge and expertise on international regulatory affairs.

According to JobzMall, the average salary range for a Senior Regulatory Affairs Specialist - International in Sylmar, Los Angeles, CA, USA is $100,000-$130,000 per year. This range can vary depending on factors such as qualifications, experience, and the specific company and industry.

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.