Principal Regulatory Affairs Specialist

Responsibilities

• Develop global regulatory strategies for product development and planning throughout the entire product lifecycle.
• Lead global regulatory submissions, including premarket submissions, pre-submissions, and clinical trial applications for medical hardware and digital health technology.
• Provide technical leadership and strategic input on complex regulatory issues to various business units.
• Anticipate regulatory obstacles and emerging issues, developing proactive solutions with cross-functional teams.
• Negotiate with regulatory authorities during the development and review process to ensure successful submission approval.
• Review and approve labeling to ensure full regulatory compliance.
• Oversee processes for maintaining annual licenses, registrations, listings, and patent information.
• Ensure compliance with post-marketing approval requirements and manage product-associated safety reporting.

Requirements

• Bachelor's Degree in a scientific discipline (e.g., Chemistry, Life Sciences, Biology) or equivalent vocational qualifications.
• Proven experience in regulatory submissions for In Vitro Diagnostic Devices and/or Medical Devices.
• Working knowledge of 21 CFR 820, ISO 13485, Medical Device Regulation (MDR), and/or In Vitro Diagnostic Regulation (IVDR).

Preferred Qualifications

• 5+ years of experience working with Class II or Class III medical devices and/or biologics/drugs.
• Regulatory Affairs Certification (RAC) is a plus.
• Experience with 510(k) applications, PMA supplements, US Device Regulations, or international medical device submissions.
• Familiarity with Quality Systems standards, clinical investigations, and ICH guidelines.
• Ability to work effectively in a highly matrixed, fast-paced, and geographically diverse business environment.
• Strong verbal and written communication skills with the ability to engage stakeholders at multiple organizational levels.

Benefits

• Career development opportunities within a global international company.
• Health Investment Plan (HIP) PPO medical coverage options.
• Excellent retirement savings plan with high employer contributions.
• Tuition reimbursement and specialized student debt/education programs.

About the Company

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans diagnostics, medical devices, nutritionals, and branded generic medicines, serving people in more than 160 countries.