Abbott
Regulatory Affairs Manager – Diabetes Care (on-site)
Abbott, Alameda, California, United States, 94501
Regulatory Affairs Manager – Diabetes Care (on-site)
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life‑changing technologies spans diagnostics, medical devices, nutritionals and branded generic medicines.
About the Role Location:
Alameda, CA – On‑site
Employment Type:
Full‑time
The Regulatory Affairs Manager will be based in our Alameda, CA location within the Diabetes Care Division. The role focuses on US premarket and postmarket submissions for continuous glucose monitoring systems, leveraging our breakthrough glucose sensing technology.
What You’ll Work On
Develop global regulatory strategies for product development and planning throughout the product lifecycle.
Analyze and compare regulatory outcomes with initial product concepts and recommend future strategies and actions.
Provide technical leadership and strategic input on complex issues and to business units.
Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams.
Create project plans and timelines.
Lead functional groups in the development of relevant data to complete a regulatory submission.
Write and edit technical documents.
Administer and meet regulatory requirements to achieve excellent compliance status with no enforcement actions.
Negotiate with regulatory authorities during the development and review process to ensure submission approval.
Review and approve labeling to ensure compliance.
Monitor emerging issues and identify solutions.
Negotiate internally and externally with regulatory agencies.
Evaluate regulatory risks of corporate policies.
Oversee processes involved with maintaining annual licenses, registrations, listings and patent information.
Ensure compliance with product post‑marketing approval requirements.
Develop, implement and manage appropriate SOPs and systems to track and manage product‑associated events.
Actively contribute to the development and functioning of the crisis/issue management program.
Analyze product‑associated problems and develop proposals for solutions.
Oversee system to ensure that product safety issues and product‑associated events are reported to regulatory agencies.
Mentor and develop junior RA team members.
Provide regulatory input for product recalls and recall communications.
Required Qualifications
Bachelor's degree or equivalent combination of education and experience.
4‑5 years’ experience in a regulated industry (e.g., medical products, nutritionals).
2‑5 years of experience in regulatory; may also consider quality assurance, R&D/support, scientific affairs, operations, or related area.
Effectively communicate verbally and in writing, and negotiate with various regulatory agencies.
Strong attention to detail and ability to organize and track complex information.
Exercise good and ethical judgment within policy and regulations.
Use in‑depth knowledge of business functions and cross‑group dependencies/relationships.
Follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues.
Strong verbal and written communications with ability to communicate and present at multiple levels.
Preferred Qualifications
5+ years’ experience with Class II/III medical devices and/or biologics/drugs; Regulatory Affairs Certification (RAC) is a plus.
Experience with 510(k) applications, PMA supplements, NDA, BLA submissions and demonstration of US Device, Combination Device, Biologics and Drug regulations.
Working knowledge of ISO and EN standards.
Familiarity with relevant Quality Systems standards, clinical investigations, ICH guidelines.
Experience with word processing, spreadsheet and presentation software.
Experience working in a cross‑division enterprise business model.
Ability to work in a highly matrixed, geographically diverse environment.
Ability to work independently with little oversight, prioritize and meet deadlines.
Strong organizational and follow‑up skills, and attention to detail.
Benefits
Career development with an international company.
Free medical coverage in our Health Investment Plan (HIP) PPO medical plan (eligible next calendar year).
Excellent retirement savings plan with high employer contribution.
Tuition reimbursement and student debt program; free education benefit for bachelor’s degree.
A company recognized as a great place to work worldwide, featuring diversity and inclusion.
Compensation The base pay for this position is $112,000.00 – $224,000.00. In specific locations, the pay range may vary from the posted range.
Equal Opportunity Statement Abbott is an Equal Opportunity Employer, committed to employee diversity.
Apply Now For more information about our benefits and to apply, visit https://www.abbottbenefits.com or submit your application through our career portal.
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About the Role Location:
Alameda, CA – On‑site
Employment Type:
Full‑time
The Regulatory Affairs Manager will be based in our Alameda, CA location within the Diabetes Care Division. The role focuses on US premarket and postmarket submissions for continuous glucose monitoring systems, leveraging our breakthrough glucose sensing technology.
What You’ll Work On
Develop global regulatory strategies for product development and planning throughout the product lifecycle.
Analyze and compare regulatory outcomes with initial product concepts and recommend future strategies and actions.
Provide technical leadership and strategic input on complex issues and to business units.
Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams.
Create project plans and timelines.
Lead functional groups in the development of relevant data to complete a regulatory submission.
Write and edit technical documents.
Administer and meet regulatory requirements to achieve excellent compliance status with no enforcement actions.
Negotiate with regulatory authorities during the development and review process to ensure submission approval.
Review and approve labeling to ensure compliance.
Monitor emerging issues and identify solutions.
Negotiate internally and externally with regulatory agencies.
Evaluate regulatory risks of corporate policies.
Oversee processes involved with maintaining annual licenses, registrations, listings and patent information.
Ensure compliance with product post‑marketing approval requirements.
Develop, implement and manage appropriate SOPs and systems to track and manage product‑associated events.
Actively contribute to the development and functioning of the crisis/issue management program.
Analyze product‑associated problems and develop proposals for solutions.
Oversee system to ensure that product safety issues and product‑associated events are reported to regulatory agencies.
Mentor and develop junior RA team members.
Provide regulatory input for product recalls and recall communications.
Required Qualifications
Bachelor's degree or equivalent combination of education and experience.
4‑5 years’ experience in a regulated industry (e.g., medical products, nutritionals).
2‑5 years of experience in regulatory; may also consider quality assurance, R&D/support, scientific affairs, operations, or related area.
Effectively communicate verbally and in writing, and negotiate with various regulatory agencies.
Strong attention to detail and ability to organize and track complex information.
Exercise good and ethical judgment within policy and regulations.
Use in‑depth knowledge of business functions and cross‑group dependencies/relationships.
Follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues.
Strong verbal and written communications with ability to communicate and present at multiple levels.
Preferred Qualifications
5+ years’ experience with Class II/III medical devices and/or biologics/drugs; Regulatory Affairs Certification (RAC) is a plus.
Experience with 510(k) applications, PMA supplements, NDA, BLA submissions and demonstration of US Device, Combination Device, Biologics and Drug regulations.
Working knowledge of ISO and EN standards.
Familiarity with relevant Quality Systems standards, clinical investigations, ICH guidelines.
Experience with word processing, spreadsheet and presentation software.
Experience working in a cross‑division enterprise business model.
Ability to work in a highly matrixed, geographically diverse environment.
Ability to work independently with little oversight, prioritize and meet deadlines.
Strong organizational and follow‑up skills, and attention to detail.
Benefits
Career development with an international company.
Free medical coverage in our Health Investment Plan (HIP) PPO medical plan (eligible next calendar year).
Excellent retirement savings plan with high employer contribution.
Tuition reimbursement and student debt program; free education benefit for bachelor’s degree.
A company recognized as a great place to work worldwide, featuring diversity and inclusion.
Compensation The base pay for this position is $112,000.00 – $224,000.00. In specific locations, the pay range may vary from the posted range.
Equal Opportunity Statement Abbott is an Equal Opportunity Employer, committed to employee diversity.
Apply Now For more information about our benefits and to apply, visit https://www.abbottbenefits.com or submit your application through our career portal.
#J-18808-Ljbffr