Senior Project Manager, Clinical Evaluation

3202 St. Jude Medical Business Services, Inc.; Los Angeles (CA); On-site; USD 90,000 - 180,000; Full time

Benefits offered by this job

Health benefits

Training and career development

401(k) retirement plans

Paid time off

Tuition assistance

Job summary

Abbott in Sylmar, CA is seeking a Regulatory CER Project Manager to oversee clinical evaluation reports and related documentation for EU CE marking and ongoing device evaluation. You will guide internal and external writers, coordinate with Regulatory Affairs, and manage CER activities across product lines.

The role requires deep knowledge of EU MDR 2017/745, MDD, and related MEDDEV guidance, with 5–7+ years in clinical research or regulatory affairs. Travel up to 10% may be required.

Qualifications

• Bachelor’s Degree in sciences, medicine, or similar discipline
• Minimum 3 years: scientific/research background, training in science/engineering or medical fields
• Strong understanding of EU MDR 2017/745, MDD 93/42/EEC; MEDDEV 2.7/1 Rev 4, and related guidelines
• Project management and/or management of people experience
• Excellent written, verbal and presentation skills; strong medical terminology

Responsibilities

• Ensure CERs and related documents are written/edited to support regulatory submissions
• Lead CER-related procedures with internal/external writers
• Coordinate responses for Notified Body questions and audit findings
• Regulatory guidance on clinical data and evaluations to product development teams
• Interact with cross-functional teams and external vendors as needed
• Develop/update policies for the clinical evaluation process and train personnel
• Act independently as decision-maker on CER regulatory issues

Skills

CER writing

Regulatory guidance

Cross-functional collaboration

Regulatory strategy

Education

Bachelor’s Degree in sciences/medicine

Master’s Degree or equivalent preferred

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 122,000 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 fingersticks.

Our location Sylmar, CA currently has an opportunity for a Project Manager, Clinical Evaluation. The primary function of a Regulatory Project Manager, Clinical Evaluations (“Clinical Evaluation Report (CER) Project Manager (PM)”) 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 Cardiac Rhythm Management product lines. The 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, CER, PMS Plan, PMCF Plan, PMCF Report, and SSCP). As such, this person has oversight of internal and external CER Medical Writers, guiding the development, update, or revision of CERs and associated documents to support the ongoing evaluation of safety and performance of Abbott medical devices in the EU and other geographies that recognize the CE Mark.

In addition, the 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 CER PM may be requested to contribute to other activities such as process improvement, risk assessment and management, and review of regulatory and informational documents such as the Clinical Development Plan (CDP), the Instructions for Use (IFU) and patient handbooks.

The CER PM also may sit in on core teams for product development, CER-related procedure development and revision, and interact with regulatory agencies’ representatives as needed. The role of the CER PM plays a significant part in new product development, as well as in the ongoing, continuous evaluation of the safety and performance and risk/benefit profile of a device over its lifecycle. The position reports to the Global Regulatory Operations Senior Manager for Clinical Evaluations.

WHAT YOU’LL DO

• Compliance with applicable corporate and divisional policies and procedures.
• Manage CER Medical Writers’ in writing and editing content of documents, and the timelines of these deliverables; must assure timelines are met.
• 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.
• Facilitate communication and exchange of documents between stakeholders (e.g., internal personnel such as Regulatory Affairs, R&D, Clinical R&D, A&P and Marketing, Library Services, Quality Engineering, Clinical Affairs, Risk Management, Program Management, as well as external vendors such as CROs, Medical Writers and Physician Reviewers).
• Provide strategic guidance on regulatory requirements, pertaining to clinical data and clinical evaluations, 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, 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

• Required Bachelor’s Degree is required. in sciences, medicine, or similar discipline highly preferred. Or an equivalent combination of education and work experience.
• Minimum 3 years: Scientific/research background; training and degree in science, engineering, or medical fields; understanding of research design, methodology, and statistics.
• Must have 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 guidance, regulations, standards and guidelines related to medical devices, clinical studies, and quality systems.
• Project management and/or management of people experience.
• Effective written, verbal and presentation skills in the area of technical/clinical 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.
• Certification is a plus (e.g., RAC and PMP).
• Able to travel as needed (<10%).
• Preferred Master’s Degree, RN, PharmD, PhD, or MD preferred.
• Experience with Good Laboratory Practice (GLP), Good Clinical Practice (GCP), or Good Manufacturing Procedures (GMP) is preferred.
• Experience with medical devices in CRM or Heart Failure, or other active implantable devices preferred.
• Audit experience (front room or back room) 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 4, the medical device directives (MDD 93/42/EEC; AIMDD 90/385/EEC) and the EU MDR 2017/745.

WHAT 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.

The base pay for this position is $90,000.00 – $180,000.00 In specific locations, the pay range may vary from the range posted.

JOB FAMILY: Regulatory Operations DIVISION: MD Medical Devices LOCATION: United States > Sylmar : 15900 Valley View Court 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), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day)

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

Abbott is an Equal Opportunity Employer, committed to employee diversity.

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

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more.

With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.

The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings.

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