Senior Regulatory Affairs Specialist – Lingo (On-site)
Job Summary
Abbott’s cutting-edge Lingo division is looking for a Senior Regulatory Affairs Specialist to join its team in Alameda, California. This on-site role will focus on shaping the regulatory strategy for biosensing medical devices and supporting the development of next-generation healthcare technology. You'll provide critical input on Class II software medical devices, support FDA submissions (510(k), PMA), and ensure regulatory compliance across the product lifecycle.
Key Responsibilities
Represent Regulatory Affairs on cross-functional teams and guide Class II software medical device regulatory requirements.
Assess documentation for medical device submissions and provide actionable regulatory guidance.
Prepare and submit robust regulatory applications (e.g., 510(k), PMA) to authorities.
Support the development and review of SOPs for emerging product offerings.
Evaluate product design, labeling, and distribution changes for regulatory impact.
Propose regulatory strategies on complex technical issues.
Ensure product compliance with post-marketing regulatory requirements.
Review and approve product labeling and promotional materials to meet regulatory standards.
Provide guidance to peers and less experienced team members where needed.
Build and maintain strong networks across departments to ensure regulatory alignment.
Required Skills & Qualifications
Bachelor’s Degree in a scientific or technical discipline (biology, chemistry, microbiology, immunology, medical technology, etc.).
Minimum 2 years of regulatory or relevant industrial experience in quality, scientific affairs, or product development/support.
Ability to lead within cross-functional teams and manage multiple priorities.
Strong written, verbal, presentation, and organizational skills.
Working knowledge of FDA Quality System Regulation (QSR).
Preferred Skills & Qualifications
Advanced degree in Engineering, Sciences, or related field.
Prior experience with FDA 510(k) or PMA submissions.
Background in software medical devices or class I/II exempt software devices.
4-6 years’ experience in regulatory affairs or closely related industry functions.
Proven problem-solving skills and the ability to work independently with minimal oversight.
Perks & Benefits
Salary Range: $86,700 – $173,300 annually.
Free medical coverage under the HIP PPO plan (eligibility post-assessment).
High employer contribution to 401(k) retirement savings plan.
Tuition reimbursement, Freedom 2 Save student debt program, FreeU bachelor’s degree education path.
Career development opportunities with a global healthcare innovator.
Company Description
Abbott is a world leader in healthcare innovation, offering transformative technologies in diagnostics, medical devices, nutrition, and pharmaceuticals. Abbott’s Lingo division pioneers biosensing wearables that empower individuals to make smarter health and nutrition decisions, shaping the future of personalized healthcare.
Work Mode
On-site – Alameda, California, United States
Call to Action
Ready to revolutionize healthcare with advanced biosensing technology? Apply now to join Abbott’s Lingo division and drive regulatory excellence in the next generation of medical devices.
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