Clinical Evaluation - Principal Project Manager - Medical Devices

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 115,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

·  Career development with an international company where you can grow the career you dream of.
·  Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
·  An excellent retirement savings plan with high employer contribution
·  Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
·  A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
·  A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

For years, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it’s glucose monitoring system, 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 fingersticks.

The Opportunity

Our location in Santa Clara, CA currently has an opportunity for a Clinical Evaluation - Principal Project Manager .  This new team member will combine understanding of scientific and research methodology, medical device regulations and guidelines, and product and therapeutic area knowledge to support Regulatory Affairs medical device submissions in the EU 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, MDCG Guidance documents, and EU MDR 2017/745. This role will support the Structural Heart and Vascular product lines.

What You’ll Work On

·  Manage, provide guidance, and oversight of CER Medical Writers’ development of Clinical Evaluation Reports and associated documents; set deliverable and project timelines and ensure timelines are met.
·  Facilitate communication and exchange of documents between stakeholders (e.g., internal personnel such as Regulatory Affairs, R&D Engineering, Clinical Engineering, A&P and Marketing, Library Services, Quality Engineering, Post-market Surveillance Group, Clinical Affairs, Risk Management, Program Management, as well as external vendors such as CROs, Medical Writers and Physician Reviewers).
·  Review, edit, and write portions, as needed, of Clinical Evaluation Reports and associated documents.
·  Participate in and/or lead the development of regulatory responses for Notified Body questions upon review of submissions.
·  Provide strategic guidance on regulatory requirements, pertaining to clinical data and clinical evaluations, to new product development teams and sustaining teams.
·  Compliance with applicable corporate and divisional policies and procedures.
·  Participate in and support internal and external 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, as appropriate, for processes and procedures relating to the clinical evaluation process, and train key personnel on them.
·  Function independently as a decision-maker on CER-related regulatory issues.
·  Execute projects within budgetary guidelines.

Required Qualifications

·  Bachelor’s Degree OR an equivalent combination of education or work experience.  
·  Minimum 3 years regulatory affairs experience, including oversight of submissions for new products and product changes in the health care industry and/or medical devices industry plus at least 1 years in an RA project management role. Solid understanding and application of business concepts, procedures and practices. Some of the required 3 years overall RA experience can be substituted with experience in a scientific/technical role in the health care industry and/or medical devices industry plus.
·  Must have well developed written, oral, interpersonal and negotiation skills.
·  Leadership competency including organizational development and project management skills.

Preferred   Qualifications

·  Bachelor’s Degree in Scientific or Engineering related area.
·  Advanced degree  
·  Scientific/research background; training and degree in science, engineering, or medical fields; understanding of research design, methodology, and statistics.
·  Thorough understanding of the EU MDR 2017/745, MDD 93/42/EEC; AIMDD 90/385/EEC; MEDDEV 2.7/1 Rev 4, MDCG Guidances on clinical evaluations, SSCP, PMCF plans and reports, and other international harmonized standards and guidelines related to medical devices, clinical studies, and quality systems.
·  Project management and/or management of people experience.
·  Strong presentation skills in relevant areas of clinical/technical applications.
·  Strong command of medical and surgical terminology.
·  Demonstrated ability to identify and adapt to shifting priorities and competing demands.
·  Highly developed interpersonal skills, and strong attention to detail.
·  5-7+ years of experience in clinical research, clinical affairs, regulatory affairs, or quality systems, in the medical device or pharmaceuticals industry.
·  3-5+ years of experience writing, reviewing or leading development of CERs and related documents in accordance with MEDDEV 2.7/1 Rev 3 and 4, the medical device directives (MDD 93/42/EEC; AIMDD 90/385/EEC) and the EU MDR 2017/745.
·  Certification is a plus (e.g., RAC and PMP).

Apply Now

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. 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.

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.

     

The base pay for this position is
$109,300.00 – $218,500.00

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Regulatory Operations

     

DIVISION:

MD Medical Devices

        

LOCATION:

United States > Santa Clara : Building A - SC

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Yes, 5 % of the Time

     

MEDICAL SURVEILLANCE:

No

     

SIGNIFICANT WORK ACTIVITIES:

Awkward/forceful/repetitive (arms above shoulder, bent wrists), Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

     
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