Olympus America Inc. Director, Post Market Sureveillance in Center Valley, Pennsylvania
A typical day for you will include:
Maintaining responsibility and accountability 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.
Maintaining responsibility 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.
Hiring, developing, and organizing a department of engineers/project managers such that the team meets all requirements in an efficient, process, results oriented manner.
Working closely with Medical Safety Office (MSO) to ensure consistency in medical evaluations is performance and documented in HHEs and safety evaluations of products.
Maintaining responsibility for working in partnership with Design Quality Assurance in resolving customer issues and developing continuous process improvement initiatives.
Working 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.
Developing and implementing programs to review literature and internet for potential complaints and AE/MDRs.
Serving as a Core leadership team member reporting directly to the VP, Market Quality and Global VP, RA/QA.
Bachelor's Degree in engineering or scientific discipline.
Minimum of 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 desired.
Experience with communicating with domestic and international regulatory bodies.
Strong analytical, organizational and communication skills.
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.
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. We’re currently looking for a Director, Post Market Surveillance to join us in our Center Valley, PA office.
Let’s inspire healthier lives, together.
The Director, PMS is responsible for establishing and maintaining a system which is both proactive (seeking information) and reactive (collecting and assessing complaints). The incumbent 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.
At Olympus, we put a lot of good back into the world, and what we do really matters. We are committed to making people’s lives healthier, safer and more fulfilling every day by crafting innovative optical and digital solutions in medical technologies, microscopy, industrial solutions, cameras, and audio recorders.
We view our relationship with and commitment to our employees with the same passion. Everything we do at Olympus is a reflection of our vision, and everyone here helps to make it a reality. We’re invested in our employees, great ideas, and how they impact the communities around us. We see the world through multiple lenses and come together to find the right answers; the best solutions.
TRUE TO YOU. TRUE TO SOCIETY. TRUE TO LIFE.
Olympus Surgical Technology America
Olympus embraces diversity and inclusion. As an Equal Opportunity Employer, our policies as well as our values prohibit unlawful discrimination based on an employee's or applicant's race, color, sex, age, physical or mental disability, national origin, religion, sexual orientation, gender identity and/or expression, marital status, genetic information, ancestry, military or veteran status, or any other federal, state or local protected classification. EOE Minorities/Females/Veterans/Disabled
Olympus Surgical Technology America at http://www.olympus-osta.com/
Director, Post Market Sureveillance
Pennsylvania, Center Valley
Headquarters Gyrus ACMI, Inc
Auto req ID:
Olympus is an Equal Opportunity Employer, and our policies prohibit unlawful discrimination based on an employee's or applicant's race, color, sex, age, physical or mental disability, national origin, religion, sexual orientation, gender identity and/or expression, marital status, genetic information, ancestry, military or veteran status, or any other federal, state or local protected classification.