Clinical Evaluation Project Manager

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 107,000 colleagues serve people in more than 160 countries

     

JOB DESCRIPTION:

For years, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it’s glucose monitoring systems, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine finger sticks. 

Our location in Plymouth, MN currently has an opportunity for a Clinical Evaluation Project M anager. The function of a Scientific Clinical Evaluation Report Project Manager (Scientific CER PM) is to combine understanding of scientific and research methodology, medical device regulations and guidelines, and product knowledge, to support Regulatory Affairs submissions for CE Marking of new devices and maintaining of CE Mark for existing devices in accordance with MEDDEV 2.7/1 Rev 4, MDD, AIMDD, and EU MDR 2017/745. This role will support the Electrophysiology product line.

The Scientific CER PM is recognized as a subject matter expert for guidelines and regulations regarding the clinical evaluation process and its consequent documents (e.g., CEP, PMS/PMCF Plan, SSCP and PSUR, and CER).  As such, this person has oversight of one or more CER Specialists guiding the development, or update, of CERs and CER-related documents.  In addition, the Scientific CER PM will interact cross-functionally with various personnel to identify and obtain relevant documentation and data on safety, performance, adverse events and risk/benefit profile of a device or devices. Moreover, the Scientific CER PM may be requested to contribute to other activities such as risk assessment and management, and review of informational documents like the Instructions for Use.  The Scientific CER PM also may sit in on core team product development, CER-related SOP development and revision, and interact with regulatory agencies’ representatives as needed.

The role of Scientific CER PM plays a significant part in new product development, as well as in the subsequent evaluation of the safety and performance of a device over its lifecycle.  The position reports to the Director of Clinical Research Regulatory (CEP CER).

WHAT YOU’LL DO

· 
Manage CER Specialists’ efforts in writing and editing of scientific content of deliverables, and the timelines of these documents.

· 
Write and edit, as needed, Clinical Evaluation Plans and Clinical Evaluation Reports, and other clinical CER deliverables.

· 
Facilitate communication and exchange of documents between stakeholders (e.g., internal personnel such as Regulatory Affairs, R&D, Clinical R&D, Sales and Marketing, Library Services, Quality Engineering, Clinical Affairs, Risk Management, Project Management, as well as external vendors such as CROs, Medical Writers and Reviewers).

· 
Provide strategic guidance on regulatory requirements to new product development teams and sustaining teams.

· 
Participate in and support audits and responses to audit findings as appropriate, in root cause analysis, preventive or corrective actions, effectiveness monitoring, and other quality metrics.

· 
Develop and update new policies, processes and SOPs for clinical evaluation process, and train key personnel on them.

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Function independently as a decision-maker on CER-related regulatory issues, and must assure that deadlines are met.

EDUCATION AND EXPERIENCE YOU’LL BRING

Required

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A college degree (Bachelor’s) is required.

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Training and degree in science, engineering, or medical fields. Scientific/research background (i.e., has understanding of research design, methodology, and statistics)

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Experience writing CERs and related documents in accordance with MEDDEV 2.7/1 Rev 3 and 4.

· 
Understanding of regulations, standards and guidelines related to medical devices clinical studies, and quality systems, including: 21 CFR (e.g., 803, 812, 814, 820, 822, and 830); MDD 93/42/EEC; AIMDD 90/385/EEC; MDR 2017/745; MEDDEV 2.7/1 Rev.  4; ISO 14971; ISO 14155; ISO 13485.

· 
Effective written, verbal and presentation skills in the area of technical/clinical applications.

· 
Strong command of medical and surgical terminology.

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Project management and/or management of people experience.

· 
3-5+ years of experience in clinical research, quality systems, or regulatory experience in medical device or pharmaceuticals industry

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Demonstrated ability to identify and adapt to shifting priorities and competing demands.

· 
Highly-developed interpersonal skills, and strong attention to detail.

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Able to travel as needed.

Preferred

· 
Post graduate degree (Masters or Doctorate)

· 
Experience in electrophysiology or other active implantable devices preferred.

· 
Experience with Good Laboratory Practice (GLP), Good Clinical Practice (GCP), or Good Manufacturing Procedures (GMP) is preferred

· 
Audit experience (front room or back room) preferred.

· 
Certification is a plus (e.g., RAC and PMP).

WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:

·  Training and career development , with onboarding programs for new employees and tuition assistance
·  Financial security through competitive compensation, incentives and retirement plans
·  Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
·  Paid time off
·  401(k) retirement savings with a generous company match
·  The stability of a company with a record of strong financial performance and history of being actively involved in local communities

Learn more about our benefits that add real value to your life to help you live fully:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. 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 and @AbbottGlobal.

     

JOB FAMILY:

Regulatory Operations

     

DIVISION:

AVD Vascular

        

LOCATION:

United States > Minnesota > Plymouth : 5050 Nathan Lane N

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Yes, 20 % 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)

     
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

     
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

     
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf