Abbott

Clinical Specialist, Post Market Surveillance

Abbott • $78K — $156K *
Burlington, MA 01803In-Person
Healthcare
Less than 5 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • Bachelor's degree in clinical, medical, scientific or healthcare fields; or an associate degree with relevant experience.
  • Excellent verbal and written communication skills for interacting at various organizational levels.
  • Strong critical thinking with attention to detail in problem solving.
  • Proficient in computer skills for reporting and data management.
  • Capable of multitasking and prioritizing in a fast-paced environment.
  • Preferred knowledge of global regulations regarding medical device reporting and complaint handling.
  • Minimum of 3 years of relevant experience required.

Responsibilities

  • Assist the department manager to ensure timely submission of global medical device reports.
  • Represent Product Surveillance in cross-functional meetings as needed.
  • Train new employees on complaint handling and maintain relevant training documentation.
  • Ensure the accuracy and completeness of complaint information.
  • Support regulatory agency inspections when required.
  • Instruct department members on product complaint investigations and provide necessary support.
  • Collaborate with team members and other departments for product complaint information.

Benefits

  • Comprehensive medical, dental, and vision insurance.
  • Retirement savings plan with company match.
  • Paid time off and holiday pay.
  • Employee assistance program and wellness initiatives.
  • Opportunities for career advancement and ongoing training.
Full Job Description


JOB DESCRIPTION:

Under the direction of the department manager, the Clinical Specialist, Post Market Surveillance is a clinical subject matter expert for the Product Surveillance Department and able to demonstrate sound independent decision making global medical device reporting and other functions relating to the investigation of product complaints.

Responsible for Medical Device Report (MDR) submission documentation and follow-up, including interaction with Complaint Analysts, Investigators, Customer Service, etc. Provide guidance on complaint expectations and record completeness.

Job Duties:
    • Assisting the department manager in ensuring all global medical device reports are filed within regulatory timeframes
    • Represents Product Surveillance at cross-functional meetings as requested or in the absence of the department manager
    • Assists in training new employees on complaint handling as well as maintaining training documents. Provides training on complaint reporting to other groups as required.
    • Ensures complaint information is maintained
    • Support inspections by regulatory agencies (e.g. FDA, TUV) as required
    • Supporting and instructing other department members as needed on product complaint investigations and devices
    • Collaborate independently with other team members and departments needing product complaint information
    • Act as a clinical subject matter expert to the Product Surveillance team members
    • Assist with and conduct investigations with customers or field staff with minimal direction, utilizing experience and knowledge of products and various types of product complaints
    • Make sound decisions regarding medical device reporting to various global regulatory agencies
    • Be able to ascertain when additional support may be needed from other teams on complaint investigations
    • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
    • Complies with U.S. Food and Drug Administration (FDA) regulations, 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, and vendors.
    • Performs other related duties and responsibilities as required.


Qualifications:
    • Four-year degree, preferably in the clinical, medical, scientific or healthcare fields; or 2-year degree with relevant experience.
    • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
    • Critical thinking and creative approach to problem solving with attention to detail.
    • Proficient computer skills are required.
    • Ability to work within a team and as an individual contributor in a fast-paced, changing environment as well as the ability to leverage and/or engage others to accomplish projects.
    • Multitasks, prioritizes and meets deadlines in timely manner.
    • Knowledge of global regulations for medical device reporting and complaint handling is preferred.


Minimum experience of 3 years

The base pay for this position is
$78,000.00 - $156,000.00
In specific locations, the pay range may vary from the range posted.

JOB FAMILY:
Operations Quality

DIVISION:
HF Heart Failure

LOCATION:
United States > Massachusetts > Burlington : 168 Middlesex Turnpike

ADDITIONAL LOCATIONS:

WORK SHIFT:
Standard

TRAVEL:
No

MEDICAL SURVEILLANCE:
Not Applicable

SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day)

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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