Senior Regulatory Specialist
Abbott Laboratories, Pleasanton, California, United States, 94566
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
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
Our mission is to help people with heart failure survive and thrive. At Abbott’s Heart Failure (HF) business, we pioneer and increase access to lifesaving, connected innovations that empower people to take control of their health by delivering seamless clinical solutions from diagnosis to monitoring and treatment.
The Opportunity Senior Regulatory Affairs Specialist – Heart Failure Division, Pleasanton, CA. As an individual contributor, you will support product development and regulatory activities, working with limited supervision and partnering across business functions.
What You’ll Work On
Direct the development of product registration submissions, progress reports, supplements, amendments, or periodic experience reports.
Interact with FDA and other regulatory agencies to expedite approval of pending registrations.
Serve as a regulatory liaison throughout the product lifecycle.
Participate in product plan development and implementation, regulatory strategy, and risk management.
Ensure timely approval of medical devices and continued approval of marketed products.
Interface directly with FDA and other regulatory agencies.
Support the product release process by creating GTS licenses or reviewing and approving requests for product release.
Conduct reviews of product and manufacturing changes for compliance with applicable regulations.
Create, review and approve engineering change orders.
Review protocols and reports to support regulatory submissions.
Support all business segment initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Comply with U.S. Food and Drug Administration (FDA) and international regulations, company policies, operating procedures, processes, and task assignments while maintaining positive and cooperative communications with all levels of employees, customers, contractors, and vendors.
Serve as a regulatory representative to marketing, research, and regulatory agencies.
Advise development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations, and interpretations.
Required Qualifications
Bachelor’s Degree (± 16 years) in a technical discipline—highly preferred or a combination of education and work experience.
Minimum 5 years of technical experience, including at least 4 years of regulatory experience in a medical device industry.
Experience with 510(k) applications, PMA supplements and U.S. device regulations.
Experience with EU and other international medical device regulations and submissions.
Experience working in a broader enterprise/cross‑division business unit model preferred.
Ability to work in a highly matrixed and geographically diverse business environment.
Ability to work within a team and as an individual contributor in a fast‑paced, changing environment.
Ability to leverage and/or engage others to accomplish projects.
Strong verbal and written communication with the ability to effectively communicate at multiple levels in the organization.
Ability to multitask, prioritize, and meet deadlines in a timely manner.
Strong organization and follow‑up skills, as well as attention to detail.
Ability to travel approximately 5%, including internationally.
Preferred Qualifications
Master’s Degree in Regulatory Affairs (± 18 years) preferred and may be used in lieu of direct regulatory experience. Minimum 3–4 years experience in a regulated industry (e.g., medical products, nutritionals). 2–3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related areas. Certification (e.g., RAC from the Regulatory Affairs Professionals Society) is a plus.
Experience reviewing labeling, promotional, or advertising materials—highly desired.
Familiarity with principles and requirements of promotion, advertising, and labeling.
Office program skills: Word, Excel, PowerPoint, Adobe Acrobat, and SharePoint.
Bachelor’s degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), regulatory affairs, engineering, or medical fields; Master’s Degree in Regulatory Affairs may be used in lieu of direct regulatory experience.
The base pay for this position is $90,000.00 – $180,000.00. In specific locations, the pay range may vary from the range posted.
#J-18808-Ljbffr
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, 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
Our mission is to help people with heart failure survive and thrive. At Abbott’s Heart Failure (HF) business, we pioneer and increase access to lifesaving, connected innovations that empower people to take control of their health by delivering seamless clinical solutions from diagnosis to monitoring and treatment.
The Opportunity Senior Regulatory Affairs Specialist – Heart Failure Division, Pleasanton, CA. As an individual contributor, you will support product development and regulatory activities, working with limited supervision and partnering across business functions.
What You’ll Work On
Direct the development of product registration submissions, progress reports, supplements, amendments, or periodic experience reports.
Interact with FDA and other regulatory agencies to expedite approval of pending registrations.
Serve as a regulatory liaison throughout the product lifecycle.
Participate in product plan development and implementation, regulatory strategy, and risk management.
Ensure timely approval of medical devices and continued approval of marketed products.
Interface directly with FDA and other regulatory agencies.
Support the product release process by creating GTS licenses or reviewing and approving requests for product release.
Conduct reviews of product and manufacturing changes for compliance with applicable regulations.
Create, review and approve engineering change orders.
Review protocols and reports to support regulatory submissions.
Support all business segment initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Comply with U.S. Food and Drug Administration (FDA) and international regulations, company policies, operating procedures, processes, and task assignments while maintaining positive and cooperative communications with all levels of employees, customers, contractors, and vendors.
Serve as a regulatory representative to marketing, research, and regulatory agencies.
Advise development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations, and interpretations.
Required Qualifications
Bachelor’s Degree (± 16 years) in a technical discipline—highly preferred or a combination of education and work experience.
Minimum 5 years of technical experience, including at least 4 years of regulatory experience in a medical device industry.
Experience with 510(k) applications, PMA supplements and U.S. device regulations.
Experience with EU and other international medical device regulations and submissions.
Experience working in a broader enterprise/cross‑division business unit model preferred.
Ability to work in a highly matrixed and geographically diverse business environment.
Ability to work within a team and as an individual contributor in a fast‑paced, changing environment.
Ability to leverage and/or engage others to accomplish projects.
Strong verbal and written communication with the ability to effectively communicate at multiple levels in the organization.
Ability to multitask, prioritize, and meet deadlines in a timely manner.
Strong organization and follow‑up skills, as well as attention to detail.
Ability to travel approximately 5%, including internationally.
Preferred Qualifications
Master’s Degree in Regulatory Affairs (± 18 years) preferred and may be used in lieu of direct regulatory experience. Minimum 3–4 years experience in a regulated industry (e.g., medical products, nutritionals). 2–3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related areas. Certification (e.g., RAC from the Regulatory Affairs Professionals Society) is a plus.
Experience reviewing labeling, promotional, or advertising materials—highly desired.
Familiarity with principles and requirements of promotion, advertising, and labeling.
Office program skills: Word, Excel, PowerPoint, Adobe Acrobat, and SharePoint.
Bachelor’s degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), regulatory affairs, engineering, or medical fields; Master’s Degree in Regulatory Affairs may be used in lieu of direct regulatory experience.
The base pay for this position is $90,000.00 – $180,000.00. In specific locations, the pay range may vary from the range posted.
#J-18808-Ljbffr