Susan Lewandowski
Manager, Program Regulatory Affairs @Olympus Corporation
Signup · Get unlimited contacts
WORK HISTORY
Manager, Program Regulatory Affairs @Olympus Corporation
EDUCATION
Temple University
MS, QA and Regulatory Affairs
Temple University
BS, Elementary Education
SKILLS
ABOUT SUSAN LEWANDOWSKI
Extensive regulatory affairs experience in the medical device and pharmaceutical industries in varying capacities and increasing levels of responsibility. Proven ability for successful leadership, influence and negotiation with demonstrated ability to coordinate multiple priorities in a fast-paced environment. Strong communication skills facilitate interaction with people at all organizational levels. Excellent interpersonal skills and adaptability.SELECTED REGULATORY CAREER HIGHLIGHTSBoth authored and led RA Medical Device submission projects for both US/EU including 510(k)s, PMAs, IDEs, HDEs, Technical Documentation, Design Dossiers, and subsequent reporting documents, as well as provided content for other international submissions. Participated in Regulatory Authority (US/EU) discussions including face-to-face meetings, teleconferences, and interactive reviews as needed for all the above submission types. Managed a team of RA professionals to complete company goals within established time frames. Provided coaching and mentoring to team members. Strong proponent of team approach to problem solving and meeting company goals.Key team member for successful execution of both internal and external (Regulatory Authority) audits; these include MDSAP, ISO, Technical File and Pre-Approval audits. Functioned as Front-Room lead, Back-Room lead, and Subject Matter Expert dependent on audit type. Experience addressing, correcting, and responding to internal and external audit observations.Experience with Corrective Action Preventive Action (CAPA) investigations and execution of action and effectiveness monitoring. Experience with investigative tools. Participated in Non-conformance investigations as needed. Key member of Product Issue Assessment (PIA) board as well as Quality Review Board (QRB) for product complaints, non-conformities, etc. CAPA Review Board (CRB) member as needed. Member of ad-hoc Due Diligence team to investigate potential acquisitions of either medical device technology or companies. Functioned as RA lead of Integration Team for an acquired medical device company.
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.