Senior Project Manager, Clinical Evaluation

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

Senior Clinical Evaluation Scientist / Project Manager 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 fingersticks. Job Description 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.

EDUCATION AND EXPERIENCE YOU'LL BRING

Bachelors Degree (± 16 years) Preferably in Life Sciences OR An equivalent combination of education and work experience Minimum 5 years Medical devices, clinical research experience, or related industry. Prefer at least 3 years of related work experience in Quality role in medical device area and/or clinical trial environment. Prefer GCP audit experience.

Specific requirements:

Fluent in English, any additional major language is a preferred asset; Excellent Communicator; Computer Literate. Preferred Master's Degree, RN, PharmD, PhD, or MD preferred. 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 (

Santa Clara :

Building

B - SC ADDITIONAL LOCATIONS

WORK SHIFT:

Standard TRAVEL:

Yes, 5 % 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