Abbott

Regulatory Affairs Intelligence Specialist

Abbott • $61K — $122K *
St. Paul, MN 55106In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • Bachelor's degree in a scientific or technical field preferred; equivalent education and experience accepted
  • 2-3 years in a regulated industry, preferably medical products
  • Familiarity with regulatory history and practices, including GxPs and product laws
  • Effective verbal and written communication skills, capable of drafting technical documents
  • Experience working with cross-functional teams and managing projects
  • Strong attention to detail and organizational skills
  • Ability to apply business and regulatory ethical standards

Responsibilities

  • Monitor and fact-check new or changing global regulations
  • Document regulations within the regulatory intelligence systems
  • Communicate emerging regulations and support implementation
  • Conduct regulatory investigations for medical device changes
  • Improve quality system procedures and documents
  • Train others on regulatory systems and processes
  • Collect and report data supporting key performance indicators

Benefits

  • Collaborative working environment with diverse teams
  • Opportunities for continual learning and development
  • Support in maintaining compliance with global regulations
  • Involvement in innovative projects within the medical devices sector
Full Job Description
JOB DESCRIPTION:

The Opportunity

This position serves as the Medical Devices Regulatory Affairs (RA) Global Regulatory Compliance process lead; collaborates cross-functionally as needed and keeps MD RA informed of key global regulatory changes and status of assessment / implementation for compliance via the QMS Process.

WHAT YOU'LL DO

Global Regulatory Operations is seeking a Regulatory Affairs Intelligence Specialist to join our team in St. Paul, MN.

This position is focused on new and changing regulations that enable global market access for new and innovative medical devices and supports compliance continuity for marketed devices. Assisting in the process to evaluate proposed regulatory changes in major markets including the US, EU, Canada, Australia, Brazil, Japan, the Regulatory Affairs Intelligence Specialist:

  • Monitors and fact-checks new or changing global regulations


  • Tracks and documents regulations within the regulatory intelligence systems


  • Supports the communication of emerging regulations, documents for comment, and regulations in implementation


  • Performs regulatory investigations to assess medical device regulatory changes within a specific country or region


  • Supports the maintenance of, or continuous improvement of quality system procedures, and documents


  • May train others on systems and processes


  • Facilitates the collection and reporting of data in support of key performance indicators


  • Gathers additional data to support interpretation, and aid businesses in determining impact


  • Support all company initiatives as identified by management and in support of Quality Management Systems (QMS) and other regulatory requirements


  • Complies with regulations, international regulations and other regulatory requirements, company policies, operating procedures, processes, and task assignments.


  • Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, etc.


  • Performs other related duties and responsibilities, on occasion, as assigned


Required Qualifications

  • Bachelors Degree (± 2 years) In science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred OR an equivalent combination of education and work experience


  • Minimum 2 years This position does not require previous regulatory experience. 2-3 years experience in a regulated industry (e.g., medical products, nutritionals). Regulatory area is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.


  • Experience with Regulatory history, guidelines, policies, standards, practices, requirements and precedents; Regulatory agency structure, processes and key personnel; Principles and requirements of applicable product laws; Submission/registration types and requirements; GxPs (GCPs, GLPs, GMPs); Principles and requirements of promotion, advertising and labeling; Domestic and international regulatory guidelines, policies and regulations; Ethical guidelines of the regulatory profession, clinical research and regulatory process. Note: This knowledge may be developed through tenure in this position.


  • Communicate effectively verbally and in writing. Communicate with diverse audiences and personnel. Write and edit technical documents.


  • Work with cross-functional teams. Work with people from various disciplines and cultures.


  • Write and edit technical documents.


  • Negotiate internally.


  • Pay strong attention to detail.


  • Manage projects. Create project plans and timelines.


  • Think analytically and critically.


  • Organize and track complex information.


  • Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.


  • Has a sound knowledge of a variety of alternatives and their impact on the business.


  • Apply business and regulatory ethical standards.


  • Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.


Preferred Qualifications

  • 2-4+ years' experience in medical devices, or a regulated industry (e.g., nutritional, pharma) preferred. Experience in a Regulatory or Quality role, a plus.


  • Ability to work within a fast-paced and matrixed team environment


  • Strong verbal and written communication skills • Strong attention to detail and organizational skills


  • Proficient in Excel, and all programs with MS Office suite (Word, PowerPoint, Outlook)


  • Experience in program management a plus


  • Experience with document management systems a plus


The base pay for this position is
$61,300.00 - $122,700.00
In specific locations, the pay range may vary from the range posted.

JOB FAMILY:
Regulatory Operations

DIVISION:
AVD Vascular

LOCATION:
United States > Minnesota > St. Paul > Lillehei : One Lillehei Plaza

ADDITIONAL LOCATIONS:

WORK SHIFT:
Standard

TRAVEL:
Yes, 5 % of the Time

MEDICAL SURVEILLANCE:
No

SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

About Abbott

Abbott Careers

Joining Abbott means becoming part of a globally diverse team dedicated to making a lasting impact on human health. As a leader in healthcare innovation, Abbott provides a dynamic workplace where careers flourish through growth, leadership, and diversity training.

Opportunities at Abbott

Explore a world of opportunities with our team. Whether you're seeking job opportunities in engineering, marketing, research, or healthcare, Abbott offers a variety of positions that allow professionals to grow their careers. Our commitment to diversity and innovation is evident in every aspect of our work, fostering an inclusive culture that values each team member's contribution.

Work You'll Do

At Abbott, every role contributes to our mission of helping people live fuller lives through better health. From groundbreaking research in medical devices to advancements in pharmaceuticals, our team is at the forefront of healthcare innovation. By joining Abbott, you are not just accepting a job; you are embarking on a path of professional and personal growth.

Internship Programs

Kickstart your career with an Abbott internship. Our programs provide invaluable industry experience and a chance to develop essential skills in a real-world setting. Interns at Abbott work on projects that matter, gaining the experience and knowledge necessary to succeed in their future careers.

Professional Development

Abbott is dedicated to the continuous professional development of its employees. With access to cutting-edge technology, leadership programs, and diversity training, our team members are equipped to lead and innovate within the healthcare industry. We support your career journey with robust training programs, mentorship, and opportunities for networking and professional growth.

Benefits and Culture

Our employees enjoy comprehensive benefits designed to support their life and well-being. From health insurance to retirement plans, we ensure our team has everything they need to thrive. Abbott's culture is built on a foundation of respect and integrity, united by a shared commitment to improving health outcomes.

Join Our Team

Discover the impact you can make with a career at Abbott. We are hiring individuals who are passionate, curious, and driven to lead. Search open positions that match your skills and interests on our Jobs page. Prepare your resume, sharpen your interview skills, and get ready to join a team that's at the cutting edge of healthcare solutions.

Stay Connected

Keep up to date with career tips, industry insights, and company news—all from the people who work here. Subscribe to our Careers Blog and personalize your subscription to receive job alerts and insider tips tailored to your preferences.

Explore Abbott

With a commitment to improving life through innovation, leadership, and diversity, Abbott is a place where you can fulfill your potential. See what exciting and rewarding opportunities await at Abbott by exploring our career opportunities today.

SEARCH ABBOTT JOBS

Join us in our mission to make the world a healthier place through innovation, leadership, and diversity. Your journey to a fulfilling career at Abbott starts here.
Learn more about Abbott
Size
113,000 employees
Market Cap
$189 billion
Industry
Healthcare
Net Income
$4.4 billion
Founded
1944
5 Year Trend
+15.6%
Revenue
$34.6 billion
NASDAQ
ABT
* Ladders Estimates

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