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Senior Principal Medical Safety Specialist

Req ID:  5769

Working Location: MASSACHUSETTS, WESTBOROUGH; California, Los Angeles; Illinois, Chicago; MINNESOTA, BROOKLYN PARK; PENNSYLVANIA, CENTER VALLEY; Texas, Houston 


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

As a Senior Principal Medical Safety Specialist (Sr. Pr. MSS) you will have an integral role in  the day-to-day functioning of the global medical safety organization. In this vital role you will facilitate, develop, and execute upon medical safety processes globally at Olympus. As an individual contributor you will lead and influence the science and practice of all medical safety activities related to the detection, assessment, understanding of product risks and their effective mitigations to protect patients worldwide. You will demonstrate the advanced ability to apply your clinical experience, product expertise, and medical safety domain knowledge to lead, collaborate, and influence patient safety in activities being performed cross-functionally across the product lifecycle for all Olympus therapeutic areas.


You will bring advanced industry experience and expertise in the fundamentals of Medical Safety practices and processes to Olympus and will report directly to the Medical Safety Director as a member of the global medical safety team.  Additionally, you will be expected to mentor and train other Medical Safety professionals and will use your established expertise to further define medical safety engagement criteria in processes throughout the Olympus product lifecycle. You must bring strong project management skills, have the ability to manage multiple medical safety projects simultaneously, and must be adept at cultivating strong collaborative relationships across Medical & Scientific Affairs as well as Infection Prevention & Control, Quality Affairs & Regulatory Affairs, Research & Development, Legal, and Health Care Compliance. 


** Remote candidates may be considered dependent upon candidate experience and qualifications.

Job Duties

* Use your advanced clinical knowledge and medical safety expertise to serve as a medical safety expert contributor to assess and understand product risk and influence and advise on mitigation strategies


* Search, review, trend, understand, and interpret adverse event data, literature, and other safety-relevant data for the purpose of signal detection


* You are considered a Medical Safety expert with knowledge and experience working with:

  • Various regulations (HIPPA, EU-MDR, FDA 21 CFR Part 803, 806, 820)
  • Various standards (GCP, ISO 13485, ISO 14971)
  • Regulatory filings (FDA IDE, 510K, EU-MDR CERs, SSCP, PMCFs, PSURs)
  • Corrective Actions – Preventative Actions (CAPAs)
  • Health Hazard Assessment & Field Corrective Actions
  • Resolving product non-conformances
  • IMDRF dictionary terms and proficiency in adverse event coding and reporting
  • Post market surveillance, escalations, and mandatory safety reporting requirements
  • Endoscopic diagnostic and therapeutic procedures in the following therapeutic areas: Gastroenterology, Pulmonary, ENT, General Surgery, Neurological Surgery, Orthopedic Surgery, Urology, Obstetrics/Genecology, Infectious Disease, Infection Prevention and Control


* Maintain knowledge of Olympus standard operating procedures, guidance, work instructions, training, and competencies


* Participate /initiate/create activities and materials related to onboarding or mentoring members of the Medical Safety team.


* Demonstrate advanced knowledge and experience in working through new product development (stage gates)


* Demonstrate strong self-motivation and individual leadership skills, including the ability to communicate and influence multi-departmental, cross functional teams and contribute to the resolution of quality-related issues in a timely and effective manner


* Demonstrate experience staying engaged with worldwide clinical practice guidelines, safety requirements, and  global Competent Authority regulations. 


* Cultivate Innovation: Creates new and better ways for the organization to be successful

Job Requirements



* BS/BA Degreed Health Care Professional – Advanced Degree preferred. 


* You must have 10-15 years of work experience that includes both: 

  • Working as Health Care Professional – (RN, DNP, PA-C, MD).  Direct patient care experience is required (Hospital, Medical, or Clinical Practice, etc with a preference for clinical experience in the areas of the Gastroenterology, Pulmonary, ENT, General Surgery, Neurological Surgery, Orthopedic Surgery, Urology, Obstetrics/Genecology, Infectious Disease, Infection prevention and control)
  • Medical Safety (Medical Device preferred to Pharma) or Risk Management (Medical Device) experience 


* Extended periods of time doing computer-based work


* Extended hours to accommodate international / intercontinental global time schedules


* While performing the duties of this job, the employee is regularly required to be independently mobile


* The employee is also required to interact in-person and virtually with peers and co-workers


Travel up to 10% may be required

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

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 || 

Nearest Major Market: Worcester

Job Segment: PLM, Project Manager, Management, Technology

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