Sara Gleco, Phd, Rac-Devices Email & Phone Number

United States

Wayne, Pa, Us

Regulatory specialist responsible for supporting sustaining and new product development activities for surgical medical devices in the US, Canada, and EU. I support product lines with a variety of characteristics including implants, reusable devices, electronic devices, sterile and non-sterile devices, and devices that incorporate software.Primary responsibilities include: - Regulatory lead for Technical Documentation submissions of Class Is, IIa, and IIb devices - Communicate with FDA and Notified Body to respond to submission deficiencies - Collaborate with international regulatory teams for product submissions in rest of world regions - Assess sustaining changes and document regulatory impact in the US, EU, and Canada - Support project teams and provide input on regulatory strategy and DHF documentation - Collaborate with marketing to develop global submission strategies for new product introduction - Review marketing communication materials to evaluate claims and document supporting evidence - Maintain regulatory data on internal systems and FDA FURLS database - Assist MDR team with MDD to MDR transition - Collaborate with functional SMEs in areas such as biocompatibility, sterility, and packaging

Durham, North Carolina, Us

Led all aspects of ISO 13485 quality system for design and development group: - Ensured device development projects were compliant with 21 CFR 820, ISO 13484, and EU MDR - Managed CAPA, supplier qualification, audits, document control, non-conformances, and training - Improved quality system processes to ensure systems were effective and efficientProduct Development and Project Management: - Managed budget, timeline, and resourcing through all phases of product development - Authored and reviewed design history file documentation for US and EU markets - Led and supported ISO 14971 risk management activities: FMEAs, URRAs, Hazards Analysis, Risk Management Plans - Supported test method development and design verification activities - Participated in human factors studies as a moderator and note-taker (summative and formative) - Supported Technical File development under EU MDR 2017/745Management and communication: - Managed 2 direct reports - Led internal and external project teams and interfaced regularly with clients - Worked directly with all business units including product development, design, finance, human resources, manufacturing, regulatory, and business development

Raleigh, North Carolina, Us

- Clarified course concepts for introductory materials science and engineering through homework assistance, review sessions, and office hours.

Raleigh, North Carolina, Us

Engineered materials interfaces for biomedical applications. Knowledgeable on topics of biomaterials, surface science, and semiconductor material properties. Experience working with wide band gap semiconductors (GaN, AlGaN).- Completed 2 research projects using effective project management and communication- Analyzed complex materials and biological data using statistical methods- Authored 3 scientific publications- Presented research posters at 2 local symposiums of ~50 people Experience working with bench top chemistry, aseptic techniques in BSL2 laboratory, and surface characterization methods included AFM, KPFM, SEM, XPS, contact angle goniometry, and optical microscopyOther responsibilities included:- Lab safety officer: kept SOPs up-to-date and promoted lab safety culture- Purchased laboratory materials: PPE, chemicals, bio assays, and AFM probes- Training: AFM and contact angle goniometer- Point of contact for lab maintenance and equipment issues

Raleigh, North Carolina, Us

- Developed documents and short lectures for lab course - Taught ~15 groups of 3-4 students to operate instruments and analyze data for 4 different experiments- Trained new teaching assistants and other users to independently perform lab procedures

Scranton, Pa, Us

- Communicated course concepts for introductory physics and mathematics as a peer tutor - Organized one-on-one meetings and regular group sessions (~2-10 students)

West Lafayette, In, Us

- Performed laboratory work as part of an NSF REU experience

Doctor Of Philosophy - Phd, Materials Science And Engineering

Bachelor Of Science - Bs, Biophysics