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Senior Clinical Evaluation Manager

Req ID:  4393

Working Location: MASSACHUSETTS, WESTBOROUGH 

 

Are you looking for a company that cares about people’s lives and health, including yours? At Olympus, we help make people’s lives healthier, safer and more fulfilling, every day. 
 
Let’s inspire healthier lives, together.

Job Description

The Senior Clinical Evaluation Manager reports directly to the Vice President, Regulatory Affairs. The individual creates CERs in support of EU-MDR regulatory approval strategies across the Endoscopic Solutions Division (ESD)/Therapeutic Solutions Division (TSD) business unit portfolio and meet timelines acc. to projects and requirements from regulations and laws. An in-depth knowledge of the EU-MDR, EU-MDD, MEDDEV 2.7.1 rev 4, and ISO 14971 Risk Management ensuring that clinical evaluation reporting activities are conducted in accordance with regulatory and company standard meeting all timeframes and targets with the highest quality. The Sr. Clinical evaluation manager collaborates with cross-functional teams across ESD and TSD business units, and within the broader Olympus organization, as appropriate.

 

The job is conducted in line with our Core Values which are: agility, empathy, long-term view, unity and integrity.

Job Duties

* Creation, update and management of CERs (Clinical Evaluation Reports) and / or SSCP( Summary of safety and clinical performance).

 

* Coordination and review of the CERs and/ or SSCPs generated by external supplier(s).

 

* Systematic analysis of clinical evidence related to Olympus products or diagnostic / therapeutic procedures by literature research in relevant data bases (e.g. Pubmed, Embase, Cochrane).

 

* Close collaboration with Product Management, Risk Management, R&D and Regulatory Affairs to provide input on deliverables, clinical research and literature evidence and support product development process needs.

 

* Planning and initiation of Post-market Clinical Follow-up activities together with Product Management.

 

* Forecasting and planning of budget for OSTA - CER (internal & supplier)/ per fiscal year

 

* Forecasting and planning of budget for OSTA - SSCP (internal & supplier)/ per fiscal year.

 

* Prepare and support audits at OSTA side.

 

* CER Manager report directly to Global Lead CER.

 

* Other duties as assigned.

Job Requirements

REQUIRED QUALIFICATIONS:

 

* Master level degree or PhD in health science related field required.

 

* Minimum of 3 years experience in CER creating required.

 

* Minimum of 3 years business experience in MedTech Industry required.

 

PREFERRED QUALIFICATIONS:

 

* Highly self-organized and efficient working style; demonstrated strong communication skills; team player

 

* Strong knowledge of applicable laws and regulations relevant to Clinical Evaluation, e.g. with EU-MDR, EU-MDD, MEDDEV 2.7.1 rev 4, ISO 14971 Risk Management.

 

* Knowledge of interpretation and analysis of scientific literature.

 

* Proficient English both spoken and written.

 

* Good knowledge of MS Office package.

We realize work isn’t just a job to you.

It’s a big part of your life, but not the only part. That’s why we offer competitive salaries, a robust 401(k) program, annual bonus program and comprehensive medical benefits, as well as tuition reimbursement, flexible schedules, parental and adoption leave, on-site services and Colleague Affinity Networks — so you can be ready for where life can take you. 

 

Olympus requires all new hires to be “fully vaccinated” against COVID-19, as defined by the Centers for Disease Control and Prevention (CDC), on or before their first day of work. Individuals who have been offered employment who have a disability, medical condition, or sincerely-held religious belief that prevents them from being vaccinated against COVID-19 are required to request and be granted a reasonable accommodation prior to their first day of work.

 

Olympus is passionate about the solutions it creates for the medical, life sciences, and industrial equipment industries, as well as cameras and audio products. For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling by helping detect, prevent, and treat disease, furthering scientific research, ensuring public safety, and capturing images of the world.

 

Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,500 employees throughout locations in North and South America. For more information, visit www.olympusamerica.com.
 

Olympus…True to You. True to Society. True to LIFE.

 

It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.

 

Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || 


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