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Program Manager / Nonclinical MDR Coordinator - 18-39481
Ref No.: 18-39481
Location: Research Triangle Park, North Carolina
Position Type:Contract
Shift:First
Job Category:Biotech/Pharmaceutical
Benefits:401K, Dental Insurance, Life Insurance, Medical Insurance, Vision Insurance
Hiring a Contract Nonclinical MDR Coordinator
Duration:  1 YEAR

Client Location:  RTP, NC
Work Schedule:  40+ Hours Weekly
Pay Rate:  $39.00 per hour
Benefits: ACA Compliant Medical Insurance

***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 intended for registration and market by preparing and reviewing required documentation related to the European Union Medical Device Directive/Medical Device Regulation..

Responsibilities
  • 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.
  • Maintain historical databases and perform searches of historical biocompatibility data, as needed.
  • 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.

To Apply for immediate consideration please send resume to Louis Moliterno at Louis.Moliterno@onboardusa.com and reference job # 18-39481 in the Subject Line and indicate the best times to contact you (please include nights and weekends if needed).
 
**Candidates must complete background and drug screenings before starting any assignment.
 
The On-Board Family of Companies conducts operations through its Corporate Headquarters located in East Windsor, NJ along with Regional Offices in New Castle, DE and Wake Forest, NC.
 
On-Board Companies provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics