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 114,000 colleagues serve people in more than 160 countries.
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.
- Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
- An excellent retirement savings plan with high employer contribution
- Tuition reimbursement, the student debt program and 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
Personalized healthcare is the future. Working on Lingo, you will help build a next-generation technology that enables individuals to make decisions about how to improve energy, lose weight or enhance athletic performance.
The Lingo team embodies a start-up culture and mindset with the backing of Abbott, a company with a rich history of healthcare innovation.
Join us and grow your career as you help Abbott shape the future of healthcare.
As an individual contributor, the Senior Regulatory Affairs Specialist will support product development and regulatory activities to commercialize products in the US on-site at our Alameda, CA location.
In this role, you will provide regulatory input on design and development activities to cross-functional teams, including software development and systems engineering members, and ensure availability of documentation to support submission activities to meet program objectives and timelines.
This is an exciting opportunity at Lingo.
What You’ll Work On
- 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
- 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.
Required Qualifications
- 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.
Preferred Qualifications
- 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.
Senior Regulatory Affairs Specialist Medical Devices
Lead regulatory training programs for Verily staff on applicable topics, such as FDA software/digital health/AI-ML guidances, ISO 13485 standards, and regionally-required licensing, certifications and/or registrations, GMP product development life cycle, regulatory submissions, listings, and/or regi...
IT Specialist (On-site) - Security Clearance Required
Additionally, the role will be responsible for providing technical guidance for directing and monitoring information systems operations while adhering to contracted service level agreements which require using judgment in maintaining IT operations, making recommendations, supporting multiple Operati...
Regulatory Affairs Specialist II – APAC - Diabetes Care (on-site)
Provides support to Regulatory Affairs management when working towards resolution of compliance issues, assuring these resolutions comply with site and division level policies and procedures and are aligned with the appropriate quality system. Advises project groups on preliminary or fully assessed ...
Regulatory Affairs Specialist
Our client, a large healthcare company is seeking a Regulatory Affairs Specialist to join their team! As the Regulatory Affairs Specialist you would provide regulatory support and expertise by developing global regulatory strategies, identifying needed registration data, obtaining this data and ensu...
Senior Director Regulatory Affairs
This position will be reporting into the SVP of Regulatory Affairs and will be supporting Clinical Regulatory and Regulatory CMC functions. Serve as a cross-functional leader within the organization to facilitate prompt and accurate regulatory documentation. Senior Director, Regulatory Affairs (Gene...
Senior Regulatory Affairs Leader : Class III Robotic-Assisted Structure Heart Platform : Original PMA
Currently seeking a new Senior Regulatory Affairs Leader to spearhead all FDA Pre-Market Approval submission activities as well as post-market supplements and international product registrations. Our client is developing a revolutionary new robotic-assisted transcatheter valve replacement platform e...
Managing Consultant, Environmental Regulatory Specialist (Senior Level)
An employee’s pay position within this range will be based on several factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, geographic location, performance, shift, travel requirements, sales or revenue-based metrics, and business or organizat...
Director/Senior Director, Regulatory Affairs, Therapeutics
It is our policy and intent to provide equal opportunity to all persons without regard to race, color, religion, political affiliation, sex/gender (including gender expression/identity, pregnancy, childbirth and related medical conditions), marital status, registered domestic partner status, sexual ...
Senior/Executive Director Regulatory Affairs
Monitor regulatory agency activities in the relevant space and maintain a global perspective on regulatory strategy. Lead regulatory strategy, provide regulatory guidance/precedents; identify, assess, and mitigate regulatory risks. Providing regulatory leadership and guidance to project teams and wo...
Senior Builder - CA - On Site
Identify, troubleshoot and resolve assembly problems by altering dimensions or installation to meet specifications; notify supervisor to obtain deviation approval as needed. We are at the forefront of an exciting new movement in the modular construction and commercial real estate industries!. Build,...