Search for More Jobs
Forward job to a friend
Apply without Registering
Apply by creating/using an account
Please enter your registered email address, and we'll email you a link to reset your password right away.
Job Title: Leader, Project/Program Mgmt./ Project Manager Level I
Location: 21 Davis Drive, Research Triangle Park, NC, 27709
Duration: 12 Months
***BS in Life Science or a closely related field required***
This position supports programs to address biocompatibility and nonclinical safety of medical devices and other relevant products produced by Client intended for registration and market by preparing and reviewing required documentation related to the European Union Medical Device Directive/Medical Device Regulation..
1. Assist and support the drafting and/or review of documents (e.g., biological evaluation reports and technical file gap assessments) as required for regulatory registration/submission, regulatory compliance and support of product marketing under the European Union Medical Device Directive/Medical Device Regulation (EU MDD/MDR); this support would include review of literature and assessment of compliance to biocompatibility standards, in particular ISO 10993.
2. Maintain historical databases and perform searches of historical biocompatibility data, as needed.
3. Maintain knowledge of medical device regulations and biocompatibility standards (notably ISO 10993) to assure compliance and conformance of Client CPDT programs for evaluation of medical devices and other products.
Bachelor’s degree in life science or a closely related field required, and 1 to 3 years of pre-clinical medical device development experience OR Master’s degree in life science or a closely related field and 0 to 2 years pre-clinical medical device development experience.
A broad background in biology/biocompatibility, toxicology and analytical chemistry including familiarity with recent methodologies and evaluation techniques as well as an understanding of the regulatory standards related to EU MDD/MDR (i.e., ISO 10993 and related standards). Experience in a regulated medical device industry setting preferred. Ability to communicate and work effectively with national and international, internal teams. Must be able to multitask and operate effectively within a diverse work environment. Must be team oriented and have strong interpersonal skills and customer focus but also be able to function independently. Must have excellent scientific written and verbal communication skills. Proficiency in Microsoft Office suite of applications including Access, Word, Excel, SharePoint and OneDrive.
Note: Reporting of adverse events related to use of medical devices (i.e, medical device reporting (MDR) per US FDA; pharmacovigilance activities) is NOT within the scope of skills, experience, and knowledge for this position.
Apply by creating/using an account
About LanceSoft Inc
Lancesoft is one of fastest growing and largest clinical staffing firm in the U.S. and an employer-of-choice for over 1000+ consultants - this may be your opportunity to join us!
We recruit top-notch talent for Healthcare, Pharmaceutical, Technology, Telecom, Retail and Distribution, Energy & Utilities, Banking/ Finance, Manufacturing, Automobile, Media, Transportation, and Government clients coast-to-coast across the US, Canada and India. We are one of the fastest-growing companies in the industry and
Want to read more about LanceSoft?
Click here to visit our website - www.lancesoft.com
Minorities/ Females/ Disabled/ Veterans/ Gender Identity/ Sexual Orientation