Clinical Evaluation Manager - Center Valley, United States - Olympus Corporation of the Americas

Olympus Corporation of the Americas

Verified Company

Center Valley, United States

1 week ago

Posted by:

Mark Lane

beBee recruiter

Description

Workplace Flexibility:

Field**Are you looking for a company that cares about people's lives and health, including yours? Let's inspire healthier lives, together.

Olympus, a leading medical technology company, has focused on making people's lives better for over 100 years.

Our Purpose is to make people's lives healthier, safer, and more fulfilling.

Our Core Values are reflected in all we do: _Integrity - Empathy - Agility - Unity - Long-Term View_

We deliver on our purpose and our core values by staying
True to Life.
The Clinical Evaluation Manager reports directly to the Regional Lead, Clinical Evaluation Reporting, MSA.

The individual creates CERs in support of EU-MDR regulatory approval strategies across the Endoscopic Solutions Division (ESD)/Therapeutic Solutions Division (TSD) and 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 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 Postmarket Clinical Followup activities together with Product or Marketing Management
Prepare and support audits at OSTA side
CER Manager report directly to Regional Lead CER
Other duties as assigned

Job Qualifications:

Required:

Master level degree plus 5 years of experience 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.
Highly selforganized and efficient working style demonstrated strong communication skills
Teamplayer
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
Remote work

Why join Olympus?

_ Here, people matter—our health, our happiness, and our lives._

Competitive salaries, annual bonus and 401(k)* with company match
Comprehensive Medical, Dental, Visions coverage effective on start date
24/7 Employee Assistance Program
Free virtual live and ondemand wellness classes
Worklife balance supportive culture with hybrid and remote roles
12 Paid Holidays
Educational Assistance
Parental Leave and Adoption Assistance
Volunteering and charitable donation match programs
Diversity & Inclusion Programs including Colleague Affinity Networks
On-Site Child Daycare, Café, Fitness Center** _US Only_

- **Limited locations_

About us:

Our Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and mínimally invasive procedures to improve clinical outcomes, reduce costs, and enhance the quality of life for patients and their safety.

Olympus is dedicated to building a diverse, inclusive and authentic workplace
We recognize diversity in people, views and lifestyle choices and emphasize the importance of inclusion and mutual respect.

We strive to continue to foster empathy and unity in the workplace so that our employees can fully contribute and thrive.

**_
Let's realize your potential, together._**Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Medical Affairs