Location: Pleasanton, CA
Employment Type: Full-Time
Salary Range: $112,000 – $224,000 (varies by location)
Abbott is a global healthcare leader dedicated to helping people live fully at every stage of life. Our life-changing technologies span the healthcare spectrum, including diagnostics, medical devices, nutritionals, and branded generic medicines. Our 114,000 colleagues serve people in over 160 countries.
At Abbott, you can:
Do work that matters while growing your career globally.
Access free medical coverage through our Health Investment Plan (HIP) PPO.
Benefit from an excellent retirement savings plan with high employer contribution.
Utilize tuition reimbursement, Freedom 2 Save student debt program, and FreeU education benefits.
Work for a company recognized as a great workplace worldwide, celebrated for diversity, inclusivity, and innovation.
We are seeking a Regulatory Affairs Manager to join our Heart Failure Division. This is an individual contributor role focused on enabling the development, manufacturing, and distribution of products that comply with global regulatory requirements.
The Regulatory Affairs Manager:
Combines scientific, regulatory, and business expertise.
Provides department-level guidance and is recognized as an expert resource.
Supports cross-functional teams to gather and present regulatory data for worldwide product registration.
Anticipate regulatory obstacles and emerging issues.
Lead functional groups to complete regulatory submissions.
Understand regulatory guidelines, policies, standards, and precedents.
Interpret and apply domestic and international regulatory requirements.
Compile, prepare, review, and submit regulatory submissions.
Ensure compliance with ethical guidelines in clinical research and regulatory processes.
Effectively communicate verbally and in writing.
Write and edit technical and regulatory documents.
Collaborate with cross-functional teams across disciplines and cultures.
Negotiate with regulatory agencies and internal stakeholders.
Present regulatory plans clearly to senior leadership.
Define regulatory strategy and perform risk assessment/analysis.
Manage multiple priorities and solve complex problems analytically.
Organize and track complex information effectively.
Exercise judgment within policy and regulatory frameworks.
Lead functional groups in developing data for regulatory submissions.
Develop, communicate, and build consensus for division goals.
Provide guidance to achieve business objectives.
Lead cross-functional or cross-divisional project teams.
Serve as a technical leader and mentor within the organization.
Bachelor’s degree in a technical discipline (or equivalent experience).
Minimum 6 years of Regulatory experience.
Experience with 510(k) applications, IDEs, PMA, PMA supplements, and US device regulations, or EU/international medical device regulations and submissions.
Ability to work in a matrixed, geographically diverse environment.
Strong verbal, written, and organizational skills; ability to prioritize and meet deadlines.
Experience managing complex projects independently and proactively.
Advanced degree in science, engineering, or medical fields.
8+ years of regulatory experience.
Experience in cross-division business models.
Supervisory/managerial experience.
Knowledge of US, EU (MDR), and other international regulatory requirements.
Experience with medical device software and related regulations.
RAC certification or similar credential is a plus.
Access comprehensive health and wellness benefits.
Grow your career with global opportunities.
Be part of a company committed to diversity, innovation, and improving lives.
Learn more: www.abbottbenefits.com
Connect with us: Abbott.com, Facebook, Twitter
Abbott is an Equal Opportunity Employer, committed to employee diversity.
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Pondicherry (Puducherry) |Jharkhand :
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Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |Georgia :
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