Regulatory Compliance Specialist III

2 weeks ago

Alameda, California, United States Abbott Laboratories company Full time

About Abbott
At Abbott, we offer opportunities that matter, allowing you to grow, learn, and maintain a healthy work-life balance.


Benefits You Will Enjoy:
  • Career advancement opportunities within a global organization.
  • Comprehensive medical coverage for employees through the Health Investment Plan (HIP) PPO.
  • Robust retirement savings plan with significant employer contributions.
  • Tuition reimbursement and programs to assist with student debt, making higher education accessible.

Recognized globally as a leading employer, Abbott has been honored as one of the most admired companies by Fortune and is celebrated for its commitment to diversity and inclusion.

Position Overview
The Regulatory Affairs Specialist III will play a crucial role in our Diabetes Division, focusing on the APAC region. This position is pivotal in ensuring the quality system's effectiveness and supporting daily operations related to change control.

Key Responsibilities:
- Manage regulatory activities for APAC markets to facilitate product launches and compliance.
- Maintain a solid understanding of relevant laws and regulations in the assigned APAC countries.
- Collaborate with supervisory staff to execute regulatory requirements for product development and submissions.
- Advise project teams on regulatory strategies and ensure alignment with division goals.
- Establish project objectives and ensure they align with departmental priorities.

In this role, you will also:
- Support management in resolving compliance issues while adhering to site policies and quality systems.
- Analyze product changes and their impact on submissions.
- Assist APAC affiliates in negotiations with regulatory agencies on product-related matters.
- Review submission documents and provide necessary approvals within established parameters.

Qualifications:
- A Bachelor’s Degree in a relevant technical field such as biology, chemistry, or medical technology, or an equivalent combination of education and experience.
- A minimum of 5 years of experience in Regulatory Affairs is required.

Preferred Qualifications:
- Experience with medical devices and software products.
- RAPS Certification is a plus.

At Abbott, we are committed to fostering a diverse workplace and are proud to be an Equal Opportunity Employer.

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