Abbott
Regulatory Affairs Manager – Diabetes Care (on-site)
Abbott, Alameda, California, United States, 94501
Overview
Abbott is a global healthcare leader with products in diagnostics, medical devices, nutritionals and branded generic medicines. Abbott has 114,000 colleagues serving people in more than 160 countries.
JOB DESCRIPTION:
Working 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. Abbott offers benefits and development opportunities to its employees.
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 to business units.
Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with 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/regulatory requirements to achieve excellent compliance status with no enforcement actions.
Negotiate with regulatory authorities during development and review to ensure submission approval.
Review and approve labeling to ensure compliance.
Monitor emerging issues and identify solutions; negotiate with regulatory agencies as needed.
Evaluate regulatory risks of corporate policies.
Oversee processes for maintaining annual licenses, registrations, listings and patent information.
Ensure compliance with post-marketing requirements.
Develop, implement and manage SOPs and systems to track and manage product-associated events.
Contribute to crisis/issue management program and analyze product-associated problems with proposals for solutions.
Oversee reporting of product safety issues to regulatory agencies and manage recalls with regulatory input as needed.
Mentor and develop junior Regulatory Affairs team members.
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). Higher education may compensate for years of experience.
2–5 years of regulatory experience preferred, but related areas such as quality assurance, R&D/support, scientific affairs, operations may be considered.
Effective verbal and written communication; ability to prepare and negotiate with regulatory agencies.
Ability to work effectively on cross-functional teams.
Strong attention to detail and ability to organize and track complex information.
Ethical judgment within policy and regulations; knowledge of business functions and cross-group dependencies.
Ability to identify regulatory scientific data needs and solve regulatory issues; strong communication at multiple organizational 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), PMA, NDA, BLA submissions and US device/drug regulations.
Working knowledge of ISO/EN standards and Quality Systems, clinical investigations, ICH guidelines.
Experience with word processing, spreadsheets and presentation software.
Experience in a matrixed, cross-division environment and in fast-paced settings.
Ability to work independently and as part of a team; strong project leadership and multitasking.
Additional Information Apply with the understanding that Abbott is an Equal Opportunity Employer, committed to employee diversity.
Benefits information is available at Abbott benefits resources. Further corporate information: Abbott corporate site and social channels may be consulted for updates.
Location and Other Details Location: United States – Alameda, CA (2901 Harbor Bay Parkway). Regulatory Operations, Division: ADC Diabetes Care. Travel: Yes, up to 10%.
The base pay for this position is
$112,000.00 – $224,000.00. In specific locations, the pay range may vary from the range posted.
EEO is the Law: Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law links are provided in the original description.
#J-18808-Ljbffr
JOB DESCRIPTION:
Working 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. Abbott offers benefits and development opportunities to its employees.
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 to business units.
Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with 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/regulatory requirements to achieve excellent compliance status with no enforcement actions.
Negotiate with regulatory authorities during development and review to ensure submission approval.
Review and approve labeling to ensure compliance.
Monitor emerging issues and identify solutions; negotiate with regulatory agencies as needed.
Evaluate regulatory risks of corporate policies.
Oversee processes for maintaining annual licenses, registrations, listings and patent information.
Ensure compliance with post-marketing requirements.
Develop, implement and manage SOPs and systems to track and manage product-associated events.
Contribute to crisis/issue management program and analyze product-associated problems with proposals for solutions.
Oversee reporting of product safety issues to regulatory agencies and manage recalls with regulatory input as needed.
Mentor and develop junior Regulatory Affairs team members.
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). Higher education may compensate for years of experience.
2–5 years of regulatory experience preferred, but related areas such as quality assurance, R&D/support, scientific affairs, operations may be considered.
Effective verbal and written communication; ability to prepare and negotiate with regulatory agencies.
Ability to work effectively on cross-functional teams.
Strong attention to detail and ability to organize and track complex information.
Ethical judgment within policy and regulations; knowledge of business functions and cross-group dependencies.
Ability to identify regulatory scientific data needs and solve regulatory issues; strong communication at multiple organizational 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), PMA, NDA, BLA submissions and US device/drug regulations.
Working knowledge of ISO/EN standards and Quality Systems, clinical investigations, ICH guidelines.
Experience with word processing, spreadsheets and presentation software.
Experience in a matrixed, cross-division environment and in fast-paced settings.
Ability to work independently and as part of a team; strong project leadership and multitasking.
Additional Information Apply with the understanding that Abbott is an Equal Opportunity Employer, committed to employee diversity.
Benefits information is available at Abbott benefits resources. Further corporate information: Abbott corporate site and social channels may be consulted for updates.
Location and Other Details Location: United States – Alameda, CA (2901 Harbor Bay Parkway). Regulatory Operations, Division: ADC Diabetes Care. Travel: Yes, up to 10%.
The base pay for this position is
$112,000.00 – $224,000.00. In specific locations, the pay range may vary from the range posted.
EEO is the Law: Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law links are provided in the original description.
#J-18808-Ljbffr