Number of Applicants
:000+
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 114,000 colleagues serve people in more than 160 countries.
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:
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
The function of a Senior Medical Writer/Project Manager supporting our Structural Heart Clinical Evaluation Products combines 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 the European Commission Guidelines on Medical Devices: Clinical Evaluation : A Guide for Manufacturers and Notified Bodies under Directives 93/42/EEC and 90/385/EEC (2016)requirements (MEDDEV 2.7/1 Rev 4) and EU Regulation 2017/745.
The CER Writer/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 medical writers guiding the development, or update, of CERs and CER-related documents. In addition, the CER Writer/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 CER Writer/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 CER Writer/PM will sit on core team product development, CER-related SOP development and revision, and interact with regulatory agencies’ representatives as needed.
The role of Scientific CER Writer/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 Sr. Manager of Clinical Evaluations Global Regulatory Operations and will work on-site out of our Santa Clara, CA or Maple Grove, MN location.
What You’ll Work On
Required Qualifications
Preferred Qualifications
* 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 $83,600.00 – $167,200.00. In specific locations, the pay range may vary from the range posted.
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