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Regulatory Affairs Expert
2 months ago
Join Abbott Laboratories
At Abbott, you will engage in meaningful work that contributes to your personal growth and professional development, while also caring for your well-being and that of your family.
Benefits Include:
- Opportunities for career advancement within a global organization.
- Comprehensive medical coverage for employees through the Health Investment Plan (HIP) PPO.
- A robust retirement savings plan with significant employer contributions.
- Tuition reimbursement programs, the Freedom 2 Save student debt initiative, and the FreeU education benefit to support your educational goals.
Abbott is consistently recognized as a premier workplace across numerous countries and has been acknowledged by Fortune as one of the most admired companies globally.
This position of Regulatory Affairs Specialist III is situated within our Diabetes Care Division, focusing on innovative solutions for diabetes management through advanced technology.
Key Responsibilities:As a key contributor, you will undertake specialized tasks and analyses related to the preparation and submission of regulatory documentation for global market access, ensuring compliance with regulatory agency standards.
Your contributions will include:
- Developing comprehensive regulatory submissions for both FDA and international agencies to meet departmental goals.
- Reviewing and approving engineering modifications.
- Collaborating with cross-functional teams to assess regulatory guidelines and project requirements.
- Evaluating communications to ensure they meet regulatory standards and provide essential details.
- Maintaining up-to-date knowledge of domestic and international medical device regulations to ensure compliance.
- Facilitating communication of regulatory updates to relevant personnel.
- Interfacing with regulatory bodies as necessary.
- Supporting product release processes through license creation and approval of release requests.
- Reviewing protocols and reports to aid regulatory submissions.
- Contributing to quality management systems and other regulatory initiatives.
To be considered for this role, candidates should possess:
- A Bachelor's Degree or equivalent combination of education and experience.
- A minimum of 3 years of relevant experience, including at least 2 years in regulatory affairs.
- Experience with 510(k) applications, PMA supplements, or international medical device regulations.
- The ability to thrive in a complex, matrixed environment.
- Strong communication skills, both verbal and written, with the ability to engage effectively at various organizational levels.
- Excellent organizational skills and attention to detail.
- The capability to manage multiple tasks and meet deadlines efficiently.
Additional qualifications that would be advantageous include:
- A degree in a scientific or technical discipline.
- A Master's degree.
- Experience in a cross-division business model.
- Prior experience in the Medical Device sector.
- Certification from the Regulatory Affairs Professionals Society.
- Familiarity with digital health technologies and regulatory frameworks.
At Abbott, we are committed to fostering a diverse and inclusive workplace. We believe in the importance of building a future where everyone can thrive.
