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Leader, Project/Program Mgmt
Ref No.: 18-27699
Location: Research Triangle Park, North Carolina
Job Title: Leader, Project/Program Mgmt./ Project Manager Level I
Location: 21 Davis Drive, Research Triangle Park, NC, 27709
Duration: 12 Months

 
General Function: 

***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.. 

Responsibilities: 

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. 

Position Requirements: 


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.