The Director PMS is responsible for establishing and maintaining a system which is both proactive (seeking information) and reactive (collecting and assessing complaints). The Director PMS shall have direct leadership accountability and oversight of a PMS system for assessing the following data sources on OSTA products: adverse events (AEs) complaints product feedback customer requirements and market needs patient follow-up after clinical trials/investigations service reports scientific papers in peer- reviewed journals reports on similar products by competitors compliance related communications from regulatory agencies and changes to relevant standards and regulations.

Job Duties

Responsible and accountable for the development management and execution of OSTA PMS procedures local work instructions practices and compliance of complaint and reporting performance working in a cross- functional team with other OSTA management/departments.
Responsible for cross functional teams that evaluate product risk and potential safety issues.
The teams will assess serious injuries and malfunctions in support of regulatory agency product surveillance requirements and ensure the timely initiation and completion of HHEs and regulatory filings if applicable.
The incumbent will hire develop and organize a department of engineers/project managers such that the team meets all requirements in an efficient process results oriented manner.
The Director will work closely with Medical Safety Office (MSO) to ensure consistency in medical evaluations is performance and documented in HHEs and safety evaluations of products.
Responsible for working in partnership with Design Quality Assurance in resolving customer issues and developing continuous process improvement initiatives.
Work with OSTA management and Design QA to ensure field performance and safety issues are properly addressed for new product requirements and/or risk management files.
This individual will develop and implement programs to review literature and internet for potential complaints and AE/MDRs.
Serves as a Core leadership team member reporting directly to the VP Market Quality and Global VP RA/QA.

Job Qualifications

Required:

Bachelor of Science engineering or scientific discipline
Minimum of seven (7) years management level experience in a drug/device manufacturer/distributor with strong concentration in QSR compliance and quality assurance.
Demonstrated experience in developing and leading a top performing RA team is required.
Proficient understanding of medical device regulations which include complaint handling adverse event reporting and recalls/FSCAs.
Professional certification in Regulatory Affairs Professional Society is desirable.
Experience with communicating with domestic and international regulatory bodies.
Strong analytical organizational and communication skills required.

#LI-Hybrid

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 on-demand wellness classes
Work-life 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

We care about your health and financial well-being and offer the resources you need to feel vital, confident and ready for wherever life takes you. Learn more about our benefit offerings at https://www.olympusamerica.com/careers/benefits-perks.

About us:

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

Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit www.olympusamerica.com.

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.

Olympus requires all US 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.

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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