Regulatory Affairs Specialist II – Lingo

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

Job summary

Abbott in Alameda, CA is seeking a Regulatory Affairs Specialist II to perform specialized regulatory submissions for medical devices and guide product entries through FDA and international requirements. On-site role with cross-functional collaboration across engineering, QA, and marketing.

You will evaluate regulatory guidelines, maintain up-to-date submission systems, and support the product release process to ensure compliant, timely market entry for Abbott's Lingo platform.

Qualifications

• Bachelor’s degree (or equivalent) in a regulated industry is required.
• 2-3 years’ experience in a regulated industry (e.g., medical products, nutritionals). Regulatory area preferred.
• Strong verbal and written communications with ability to communicate at multiple levels.

Responsibilities

• Prepare regulatory submissions for devices to achieve objectives.
• Review and approve engineering change orders related to documentation.
• Review regulatory guidelines and ensure compliance across global regulatory standards.
• Maintain up-to-date domestic and international medical device regulations in systems.

Skills

Regulatory knowledge

Strong communication

Team collaboration

Regulatory submissions

Education

Bachelor’s degree (or equivalent)

Bachelor’s degree in science (biology, chemistry, microbiology, etc.), math, engineering, or medical fields

Master’s degree in Regulatory Affairs

Job description

JOB DESCRIPTION:

Working at Abbott

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, 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.

What You’ll Work On

• 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).

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.

The base pay for this position is

$81,500.00 – $141,300.00

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Regulatory Operations

DIVISION:

LNGO Lingo

LOCATION:

United States > Alameda : 2901 Harbor Bay Parkway

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