Regulatory Affairs Specialist II – Lingo (on-site)

Abbott; Alameda (CA); On-site; USD 82,000 - 141,000; Full time

Job summary

Abbott in Alameda, CA seeks a Regulatory Affairs Specialist II to join on-site. The role involves preparing regulatory submissions, reviewing engineering changes, and ensuring compliance with FDA and international regulations.

You will collaborate with marketing and cross-functional teams to support product launches and lifecycle activities. The position requires 2–3 years in a regulated industry, a Bachelor’s degree, and strong communication skills.

Qualifications

• Bachelor’s degree (or equivalent).
• 2–3 years’ experience in a regulated industry (e.g., medical products).
• Ability to work within a team in a fast-paced, matrixed environment.
• Strong verbal and written communications across multiple levels.

Responsibilities

• Prepare regulatory submissions for devices to meet department objectives.
• Review and approve engineering change orders and related documentation.
• Act as regulatory representative for applicable guidelines (FDA and international).
• Maintain up-to-date domestic and international medical device regulations.
• Collaborate with marketing to review advertising and promotional materials.

Skills

Regulatory knowledge

Communication skills

Teamwork

Adaptability

Education

Bachelor's degree

Job description

JOB DESCRIPTION: Working at Abbott

Abbott is a global healthcare leader that helps 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. Our 122,000 colleagues serve people in more than 160 countries. At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to: Career development with an international company where you can grow the career you dream of. Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. An excellent retirement savings plan with high employer contribution Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree. A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune. A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

ABOUT LINGO

Meet Lingo, a new biosensing technology that provides users a window into their body. Lingo tracks key biomarkers – such as glucose, ketones, and lactate – to help people make better decisions about their health and nutrition. Biowearable technology will digitize, decentralize and democratize healthcare, enabling consumers to take control of their own health.

The Opportunity

Abbott is seeking a passionate, experienced Regulatory Affairs Specialist II to join our team on-site in Alameda, CA. In this role, you will perform specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for regulatory registration, ensuring products and procedures comply with regulatory agency specifications. Supports necessary regulatory activities required for product market entry.

• Preparation of regulatory submissions for devices to achieve departmental and organizational objectives.
• Review and approve engineering change orders for protocols, reports, specifications, and other project related documentation supporting both new product development projects and sustaining activities.
• Acts as a regulatory representative responsible for review and analysis of applicable regulatory guidelines.
• Reviews and evaluates communications to ensure communications convey all necessary detail and adhere to applicable regulatory standards including those set by the FDA or other worldwide regulatory agencies to various international affiliates.
• Maintains pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission data base and file systems.
• Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel, if requested.
• Supports the product release process by collaborating with the Regulatory Operations team and ensuring products are released in a compliant and timely manner to support Abbott customers.
• Collaborate with marketing team in review and approval of advertising and promotional materials.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) regulations, international regulations and other regulatory requirements, company policies, operating procedures, processes, and task assignments.
• Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Performs other related duties and responsibilities as assigned.

Required Qualifications

• Bachelor’s degree (or equivalent)
• 2-3 years’ experience in a regulated industry (e.g., medical products, nutritionals).
• Regulatory area is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
• Note: Higher education may compensate for years of experience.
• Ability to work within a team environment and accomplish projects within a fast-paced, matrixed environment.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.

Preferred Qualifications

• Bachelor’s degree in science (biology, chemistry, microbiology, etc.), math, engineering, or medical fields.
• Master’s degree in Regulatory Affairs.
• Regulatory experience with capital equipment including software, firmware, graphical user interfaces, and associated hardware.
• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).

The base pay for this position is $81,500.00 – $141,300.00

JOB FAMILY: Regulatory Operations DIVISION: LNGO Lingo LOCATION: United States > Alameda : 2901 Harbor Bay Parkway

ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 5 % of the Time MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES:

• Awkward/forceful/repetitive (arms above shoulder, bent wrists)
• Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.

We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

Follow Us: Facebook LinkedIn YouTube Twitter