Abbott Laboratories
Senior Clinical Scientist - Project Manager
Abbott Laboratories, Santa Clara, California, us, 95053
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: Career development with an international company where you can grow the career you dream of.
Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
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 The primary function of a
SENIOR CLINICAL EVALUATION SCIENTIST/PROJECT MANAGER
is to 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
Vascular
product lines. WHAT YOU’LL DO Manage, provide guidance, and oversight of CER Medical Writers’ development of Clinical Evaluation Reports and associated documents;
set deliverables 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.
Draft and/or lead the development of regulatory responses for Notified Body and regulators’ 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.
Required Bachelors
Degree (± 16 years) Minimum 5 years within healthcare-focused regulatory and/or compliance Preferred Qualifications A college degree (Bachelor’s) is
required
.
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 Guidance 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 experience.
Excellent written,
verbal
and 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.
Proven ability to deliver high-quality work within tight timelines.
Highly-developed
interpersonal skills, and strong attention to detail.
Able to travel as needed (
Master’s Degree, RN, PharmD, PhD, or MD preferred.
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.
Knowledge of Cardiovascular devices and technologies.
The base pay for this position is $86,700.00 – $173,300.00. In specific locations, the pay range may vary from the range posted.
#J-18808-Ljbffr
You’ll
also have access to: Career development with an international company where you can grow the career you dream of.
Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
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 The primary function of a
SENIOR CLINICAL EVALUATION SCIENTIST/PROJECT MANAGER
is to 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
Vascular
product lines. WHAT YOU’LL DO Manage, provide guidance, and oversight of CER Medical Writers’ development of Clinical Evaluation Reports and associated documents;
set deliverables 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.
Draft and/or lead the development of regulatory responses for Notified Body and regulators’ 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.
Required Bachelors
Degree (± 16 years) Minimum 5 years within healthcare-focused regulatory and/or compliance Preferred Qualifications A college degree (Bachelor’s) is
required
.
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 Guidance 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 experience.
Excellent written,
verbal
and 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.
Proven ability to deliver high-quality work within tight timelines.
Highly-developed
interpersonal skills, and strong attention to detail.
Able to travel as needed (
Master’s Degree, RN, PharmD, PhD, or MD preferred.
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.
Knowledge of Cardiovascular devices and technologies.
The base pay for this position is $86,700.00 – $173,300.00. In specific locations, the pay range may vary from the range posted.
#J-18808-Ljbffr