ABBOTT LABORATORIES Project Manager - Regulatory Affairs (Medical Devices) Salary in the United States

How much does a Project Manager - Regulatory Affairs (Medical Devices) make at companies like ABBOTT LABORATORIES in the United States? The average salary for Project Manager - Regulatory Affairs (Medical Devices) at companies like ABBOTT LABORATORIES in the United States is $95,100 as of June 27, 2024, but the range typically falls between $82,434 and $107,765. Salary ranges can vary widely depending on many important factors, including education, certifications, additional skills, the number of years you have spent in your profession. With more online, real-time compensation data than any other website, helps you determine your exact pay target.  View the Cost of Living in Major Cities


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What does a Project Manager - Regulatory Affairs (Medical Devices) do at companies like ABBOTT LABORATORIES?

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 103,000 colleagues serve people in more than 160 countries.

  • This NOT an IT project manager position.
  • This NOT an entry-level position.

Location: Abbott Park (Lake Bluff), IL

Primary Function:

As an individual contributor; the function of a Regulatory Affairs Project Manager is to combine knowledge of scientific; regulatory and business issues to enable products that are developed; manufactured or distributed to meet required legislation. The individual has department/group/site level influence and is generally recognized as an expert resource within the department. The individual may share knowledge and expertise with others in support of team activities. The individual may identify data needed; obtain these data and ensure that they are effectively presented for the registration of products worldwide.

Core Job Responsibilities:

Responsible for implementing and maintaining the effectiveness of the quality system. Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Core job responsibilities for this function may include:

• Develop new regulatory policies; processes and SOPs and train key personnel on them • Evaluate regulatory risks of division policies; processes; procedures • Provide regulatory input to product lifecycle planning

• Monitor regulatory outcomes of initial product concepts and provide input to senior regulatory management

• Assist in the development of multi-country regulatory strategy and update strategy based upon regulatory changes

• Assist in regulatory due diligence for potential and new acquisitions

• Utilize technical regulatory skills to propose strategies on complex issues

• Determine submission and approval requirements

• Identify emerging issues

• Monitor trade association positions for impact on company products

• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams

• Recruit; develop and mentor regulatory professionals

• Assess the acceptability of quality; preclinical and clinical documentation for submission filing

• Evaluate risk of and regulatory solutions to product and clinical safety issues during clinical phases and recommend solutions

• Compile; prepare; review and submit regulatory submission to authorities

• Monitor impact of changing regulations on submission strategies and update internal stakeholders

• Monitor applications under regulatory review

• Communicate application progress to internal stakeholders

• Monitor and submit applicable reports and ensure appropriate responses are submitted to regulatory authorities

• Evaluate proposed preclinical; clinical and manufacturing changes for regulatory filing strategies

• Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval

• Provide strategic input and technical guidance on regulatory requirements to development teams

• Manage and execute preapproval compliance activities

• Oversee processes involved with maintaining annual licenses; registrations; listings and patent information

• Ensure compliance with product post-marketing approval requirements

• Review and approve advertising and promotional items to ensure regulatory compliance

• Ensure external communications meet regulations

• 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

• Oversee system to ensure that product safety issues and product-associated events are reported to regulatory agencies

• Report adverse events to regulatory agencies and internal stakeholders

• Provide regulatory input for product recalls and recall communications

Minimum Education:

  • Bachelor's Degree (or equivalent); Bachelor's Degree in science (biology; chemistry; microbiology; immunology; medical technology; pharmacy; pharmacology); math; engineering; or medical fields is preferred.
  • M.S. in a technical area or M.B.A. is preferred.
  • A Ph.D. in a technical area or law is helpful.
  • Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)

Minimum Experience / Training Required:

  • 2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
  • 4-5 years’ experience in a regulated industry (e.g., medical products, nutritionals).

Preferred Experience, Education, etc.:

  • Regulatory work experience from medical device industry (e.g. IVD/ In Vitro Diagnostics) 
  • ISO 13485
  • Bachelor's Degree ideally in Chemistry, Biochemistry, Engineering, or similar.
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$82,434 Low Average $95,100 High $107,765

Understand the total compensation opportunity for Project Manager - Regulatory Affairs (Medical Devices) at companies like ABBOTT LABORATORIES, base salary plus other pay elements

Average Total Cash Compensation

Includes base and annual incentives

The chart shows total cash compensation for the ABBOTT LABORATORIES Project Manager - Regulatory Affairs (Medical Devices) in the United States, which includes base, and annual incentives can vary anywhere from $82,434 to $107,765 with an average total cash compensation of $95,100. Total compensation includes the value of any benefits received in addition to your salary and some of the benefits that are most commonly provided within a total compensation package including bonuses, commissions, paid time off, and Insurance. The total cash compensation may get paid differently by industry, location, and other factors.
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