Top 45 Regulatory affairs manager Jobs in Alameda, Ca

Senior Manager, Regulatory Affairs - Lingo (on-site)
Abbott Laboratories —Alameda, CA
- $130,700 - $261,300 a year
- Full-time
- Master's degree
- Bachelor's degree
- Recruiting
- Health insurance
- Tuition reimbursement
Regulatory Affairs Manager – Diabetes Care (on-site)
Abbott Laboratories —Alameda, CA
- $114,000 - $228,000 a year
- Full-time
- Office
- Master's degree
- Bachelor's degree
- Health insurance
- Tuition reimbursement
Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada - Immunology (Hybrid)
AbbVie —South San Francisco, CA
- $124,500 - $236,500 a year
- Full-time
- Hybrid work
- 6 years
- Bachelor's degree
- Senior level
- Paid holidays
- Health insurance
6d
Manager, Regulatory Affairs
Noctrix Health —Pleasanton, CA
- $150,000 - $180,000 a year
- Full-time
- Hybrid work
- 5 years
- Engineering
- Office
Quick Apply
3d
Sr Manager/Assoc Director, CMC Regulatory Affairs
Erasca —South San Francisco, CA
- $175,000 - $205,000 a year
- Remote
- 5 years
- Bachelor's degree
- Quality control
- Health savings account
- AD&D insurance
Regulatory Affairs Manager – Heart Failure (on-site)
Abbott Laboratories —Pleasanton, CA
- $114,000 - $228,000 a year
- Full-time
- 6 years
- Supervising experience
- Bachelor's degree
- Health insurance
- Tuition reimbursement
Manager, Regulatory Affairs CMC
Gilead Sciences —Foster City, CA
- $146,540 - $189,640 a year
- Full-time
- Bachelor's degree
- Continuous improvement
- Senior level
- Health insurance
- Dental insurance
Senior Manager Regulatory Affairs (Contract)
Alumis —South San Francisco, CA
- $165,000 - $195,000 a year
- Contract
- Office
- Analysis skills
- Bachelor's degree
- Health insurance
- Cell phone reimbursement
Quick Apply
Sr. Manager, Regulatory Affairs
Vaxcyte —San Carlos, CA
- $183,000 - $194,000 a year
- Full-time
- Bachelor of Science
- Bachelor's degree
- Computer skills
Senior Program Manager, Regulatory Compliance
Google —San Francisco, CA
- $164,000 - $239,000 a year
- Full-time
- Office
- Bachelor's degree
- Fair chance
3d
Regulatory Examination Manager
Block, Inc. —San Francisco Bay Area, CA
- $135,800 - $245,400 a year
- Remote
- Bachelor of Science
- 8 years
- Bachelor's degree
- Life insurance
- Retirement plan
Manager, Regulatory and Market Affairs
Pattern Energy Group LP —San Francisco, CA
- $103,000 - $138,000 a year
- Full-time
- Hybrid work
- 5 years
- Business development
- Analysis skills
- Paid holidays
- Disability insurance
Regulatory Operations Manager
Siemens Healthineers —Palo Alto, CA
- $129,900 - $178,618 a year
- Full-time
- 5 years
- Office
- Master's degree
- Disability insurance
- Health insurance
5d
Sr Manager, Regulatory Affairs CMC, Combination Products and Device
Gilead Sciences —Foster City, CA
- $157,590 - $203,940 a year
- Full-time
- Bachelor of Science
- Bachelor's degree
- Continuous improvement
- Health insurance
- Dental insurance
5d
Sr. Manager/Associate Director, Regulatory Affairs
Oruka Therapeutics —Menlo Park, CA
- $161,000 - $208,000 a year
- Office
- 8 years
- Bachelor's degree
- Employee stock purchase plan
- Health insurance
Case Manager, Senior
PG&E Corporation —Oakland, CA
- $102,000 - $152,000 a year
- Full-time
- Hybrid work
- Microsoft Excel
- Microsoft Outlook
- 5 years
8d
Healthcare Compliance Office (HCO) Program Ops Manager - Program Operations
Genentech —San Francisco, CA
- $111,790 - $207,610 a year
- Online Application
- Customer service
- Office
- 3 years
Senior Manager / Associate Director, Regulatory Affairs
Neurona Therapeutics —South San Francisco, CA
- $150,000 - $195,000 a year
- Doctor of Philosophy
- Team management
- Mentoring
Quick Apply
9d
Senior Manager – Regulatory Affairs CMC
ValueBase Consulting —San Francisco, CA
- $100 an hour
- 7 years
- Bachelor of Science
- Bachelor's degree
Senior Project Manager (Product Lifecycle Manager)
Abbott Laboratories —Pleasanton, CA
- $114,000 - $228,000 a year
- Full-time
- 7 years
- Management
- Bachelor's degree
- Health insurance
- Tuition reimbursement

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Senior Manager, Regulatory Affairs - Lingo (on-site)

Abbott Laboratories -
Alameda, CA

Apply Now

Job Details

Full-time
$130,700 - $261,300 a year

Benefits

Health insurance
Tuition reimbursement
Retirement plan

Qualifications

Staff supervision
Team supervision
Operations coordination planning
Operational excellence initiatives
Project resource management
Process improvement planning
Operations planning
Senior leadership

Full Job Description

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 115,000 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

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.

We are recruiting for a Senior Regulatory Affairs Manager to join our team on-site in Alameda, CA. In this role, you will combine knowledge of scientific, regulatory and business issues to enable products to meet required legislation. Additionally, will be responsible for compiling regulatory submissions and ensure data is effectively presented for the registration of products worldwide.

What You’ll Work On

Recruits, coaches and develops organizational talent.
Fosters a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
Creates an entrepreneurial environment.
Provides direction and guidance to exempt specialists and/or supervisory staff who exercise significant latitude and independence in their assignments.
May manage and coach a team of regulatory employees.
Keeps the organization's vision and values at the forefront of decision making and action.
Demonstrates effective change leadership.
Builds strategic partnerships to further departmental and organizational objectives.
Develops and executes organizational and operational policies that affect one or more groups by utilizing technical/professional knowledge and skills.
Monitors compliance with company policies and procedures (e.g. compliance with FDA, BSI, EEO regulations, etc.).
Makes decisions regarding work processes or operational plans and schedules in order to achieve department objectives.
Develops, monitors and appropriately adjusts the annual budget for department(s).
Develop regulatory strategies, approval schedules, and submission standards to achieve departmental and organizational objectives.
Assess proposed regulations and communicate new requirements to the organization.
Lead the RA process for Review and analyze labeling, advertising and promotional materials while working with Marketing teams to provide regulatory strategy and compliance input.
Assist with promotional content development and review for compliance before distribution.
Lead Regulatory Affairs Ad & Promo SOP development and review.

Required Qualifications

Bachelor’s Degree in a related field or an equivalent combination of education and experience
Minimum 9 years related work experience.
Provides direction and monitors progress of exempt specialists and/or supervisory staff toward departmental goals.
Monitors costs of projects and of human and material resources within a department or unit.
Monitors company-wide indicators such as market share and profitability.
Monitors external environment in area of technical or professional responsibility.
Develops and/or identifies new work processes and the improved utilization of human and material resources within the assigned or related functions or groups.
Facilitates others' participation in the continuous improvement program.
Investigates and solves problems that impact work processes and personnel within or across units or departments.
Develops and communicates a vision for the organizational unit assigned.

Preferred Qualifications

Master’s degree
Submission / registration types and requirements
Experience working with Class III implantable devices.
Effective verbal and written communication with diverse audience and team.
Analytical thinking with good problem-solving skills.
Experience managing and leading a team.
Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).
Must be able to lead and manage multiple and competing priorities and manage programs.
Working knowledge of QSR, ISO, and EN standards. Strong working knowledge of regulatory requirements for US, EU (EU MDR), and other international geographies.
Experience with medical device software requirements and software regulations.
Ability to identify risk areas and escalate issues as appropriate.

Apply Now

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

The base pay for this position is $130,700.00 – $261,300.00. In specific locations, the pay range may vary from the range posted.

Apply Now

Refine Your Search

regulatory affairs manager jobs in alameda, ca

Senior Manager, Regulatory Affairs - Lingo (on-site)

Regulatory Affairs Manager – Diabetes Care (on-site)

Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada - Immunology (Hybrid)

Manager, Regulatory Affairs

Sr Manager/Assoc Director, CMC Regulatory Affairs

Regulatory Affairs Manager – Heart Failure (on-site)

Manager, Regulatory Affairs CMC

Senior Manager Regulatory Affairs (Contract)

Sr. Manager, Regulatory Affairs

Senior Program Manager, Regulatory Compliance

Regulatory Examination Manager

Manager, Regulatory and Market Affairs

Regulatory Operations Manager

Sr Manager, Regulatory Affairs CMC, Combination Products and Device

Sr. Manager/Associate Director, Regulatory Affairs

Case Manager, Senior

Healthcare Compliance Office (HCO) Program Ops Manager - Program Operations

Senior Manager / Associate Director, Regulatory Affairs

Senior Manager – Regulatory Affairs CMC

Senior Project Manager (Product Lifecycle Manager)

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