Regulatory Affairs Specialist II
4 weeks ago
At Abbott Laboratories, we are committed to helping people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines.
We are seeking a highly motivated and detail-oriented Regulatory Affairs Specialist II to join our team. In this role, you will be responsible for providing regulatory support for diagnostic product development and commercial products, ensuring compliance with US, EU, and international regulations and standards.
Key Responsibilities:
- Reviews and approves labeling, advertising, and promotional materials, and manages translations for country registrations.
- Assists in developing regulatory strategies for new and modified products to achieve clearance/approval.
- Researches scientific and regulatory information to develop labeling requirements and reviews verification/validation and risk management reports for accuracy.
- Assesses product, manufacturing, and labeling changes for regulatory impact and compliance.
- Develops internal procedures and tools, and conducts informational or training sessions for stakeholders.
- Organizes and maintains department files and keeps informed of global regulatory information.
Requirements:
- Bachelor's degree (BS/BA) in any biological science or technical degree.
- 2-5 years experience in Regulatory Affairs with 1-3 years of progressively responsible positions.
- Good knowledge of federal regulations.
- Good knowledge of product labeling and related requirements.
- Good knowledge of quality systems in a regulated manufacturing environment.
We offer a competitive salary range of $65,900.00 – $131,900.00, depending on location. If you are a motivated and detail-oriented individual with a passion for regulatory affairs, we encourage you to apply for this exciting opportunity.
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