Senior Regulatory Affairs Specialist
4 weeks ago
Abbott Laboratories is seeking a highly skilled Senior Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and guidelines for our medical devices and pharmaceuticals.
About the Role
This is a challenging and rewarding role that requires a strong understanding of regulatory affairs, medical devices, and pharmaceuticals. You will work closely with cross-functional teams to develop and implement regulatory strategies, prepare and submit regulatory documents, and maintain compliance with regulatory requirements.
Key Responsibilities
- Develop and implement regulatory strategies to ensure compliance with regulatory requirements and guidelines.
- Prepare and submit regulatory documents, including 510(k) and PMA submissions.
- Maintain compliance with regulatory requirements, including FDA regulations and international standards.
- Collaborate with cross-functional teams to develop and implement regulatory strategies.
- Provide regulatory guidance and support to product development teams.
- Stay up-to-date with changes in regulatory requirements and guidelines.
Requirements
- Bachelor's degree in science or a related field.
- Minimum 3-4 years of experience in a regulated industry, preferably in regulatory affairs.
- Strong understanding of regulatory affairs, medical devices, and pharmaceuticals.
- Excellent communication and interpersonal skills.
- Ability to work in a fast-paced environment and prioritize multiple tasks.
What We Offer
- Competitive salary and benefits package.
- Opportunities for professional growth and development.
- Collaborative and dynamic work environment.
- Recognition and rewards for outstanding performance.
How to Apply
If you are a motivated and detail-oriented individual with a passion for regulatory affairs, please submit your application, including your resume and cover letter, to our website.
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