Senior Regulatory Affairs – Software Medical Devices (Alameda)

Regulatory Jobs; Alameda (CA); Presencial; USD 90.000 - 180.000; Tempo integral

Benefícios oferecidos por esta vaga

Career development

Free HIP medical coverage

Employer retirement plan

Tuition reimbursement

FreeU education benefit

Fortune recognition

Great place to work diversity

Resumo da vaga

Abbott is seeking a Senior Regulatory Affairs Specialist to support Lingo product development and regulatory activities for US commercialization in Alameda, CA. You will collaborate with software and systems teams to prepare regulatory submissions and ensure compliance with post-market requirements.

The role emphasizes cross-functional teamwork, problem solving, and rigorous documentation, with a focus on Class II software medical devices and 510(k)/PMA pathways. On-site opportunity in Alameda.

Qualificações

• Bachelor's Degree; preferably in a technical discipline such as biology, chemistry, microbiology, immunology, medical technology, etc.
• Minimum 2 yrs. regulatory experience and or 2 years relevant industrial experience typically with a quality; product-development/support; scientific affairs function.
• Advanced degree in Engineering, Sciences, or related discipline
• Previous experience with 510(k)/PMA submissions or class I / II exempt software devices
• Experience with software medical devices
• 4-6 years’ experience in a regulated industry. Regulatory area is preferred but may consider quality assurance, software or systems research and development, or related area.
• Ability to work effectively on cross-functional teams.
• Must be able to juggle multiple and competing priorities
• Ability to identify and solve problems and work independently with little oversight.
• Strong written, verbal, presentation, and organizational skills.
• Working knowledge of FDA QSR.
• Has a sound knowledge of a variety of alternatives and their impact on the business.

Responsabilidades

• Represent Regulatory Affairs on cross functional project teams and provide strategic input and technical guidance on product lifecycle planning and regulatory requirements for Class II software medical devices
• Assess the acceptability of documentation for medical device submissions and effectively communicate regulatory guidance
• Review and analyze labeling, advertising and promotional materials while working with Marketing teams to provide regulatory strategy and compliance input.
• Assist with promotional content development and review for compliance before distribution.
• Lead Regulatory Affairs Ad & Promo SOP development and review.
• Prepares robust regulatory applications/submissions to regulatory authorities.
• Assist in SOP development and review in support of "next-gen" product offerings.
• Evaluate proposed design, labeling, and distribution changes for regulatory impact and implement any required regulatory action
• Utilize technical regulatory skills to propose strategies on complex issues
• Ensure compliance with product post marketing requirements
• Review product labeling to ensure compliance with relevant regulatory requirements.
• Individual may provide limited work direction and guidance to peers and/or skilled non-exempt levels of employees.
• Establishes and cultivates an extensive network of support to facilitate completion of assignments.
• Influences middle management on technical or business solutions.

Conhecimentos

Cross-functional teamwork

Prioritization

Regulatory communication

Problem solving

Formação

Bachelor's Degree

Advanced degree

Descrição da vaga

Abbott is seeking a Senior Regulatory Affairs Specialist to support Lingo product development and regulatory activities for US commercialization in Alameda, CA. You will collaborate with software and systems teams to prepare regulatory submissions and ensure compliance with post-market requirements.

The role emphasizes cross-functional teamwork, problem solving, and rigorous documentation, with a focus on Class II software medical devices and 510(k)/PMA pathways. On-site opportunity in Alameda.