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Sr. Program Manager Quality/Clinical/Regulatory Affairs

Expired Job

Divihn Integration Inc Deerfield , IL 60015

Posted 5 months ago

Job: MDR Contractor

  • Regulatory Affairs
    Primary Location: Deerfield, IL or St. Paul, MN
    Organization: Client Research & Development

  • Global RA Advanced Surgery
    Schedule: Full-time
    There is a strong possibility of being extended, depending on work load and performance

Description
This role will focus on transition and compliance to the new EU Medical Device Regulation (MDR) for Client Advanced Surgery (AS) devices. We are looking for a diligent RA professional who works well across functional teams and can navigate new regulatory initiatives.

Responsibilities
1.Perform gap analysis on Technical Files and Design Dossiers based on MDD requirements with the goal to establish compliant files ready for certificate renewals
2.Organize relevant documentation in cooperation with Design Centers / other functions in compliance with MDD and MDR for the Advanced Surgery BSI following products.

Class III Product
Dermaclose
Peri-Guard/ Supple Peri-Guard
Vascular Probes
Flo-Rester
Vascu-Guard
Dura-Guard
Peri-Strips
Veritas
Preveleak
Actifuse
Actifuse Shape
Inductagraft
Actifuse ABX
Ostene

Class II Product
Biover Clamps
MCA Devices

3.Prepare and compile MDD compliant Design Dossiers / STED to support a.m. Class III renewal applications
4.Prepare and compile MDD compliant STED to support Class IIa devices renewal applications
5.Prepare and submit applications for EC certificate renewals to the Notified Body as per project plan.
6.Support applications for new product submissions based on MDD and MDR requirements.
7.Support assessments of Clinical Evaluation Reports and relevant gap analysis
8.Follow up on questions from Notified Body, resolution with the relevant functions in Client and proposal for answers (under guidance of Advanced Surgery RA)
9.Work according to given timelines and slots with high focus on timely delivery
10. Establish appropriate communication within regulatory and other functions.
11. Monitor and apply regulatory requirements; apply appropriate principles based on product risk classification; and ensure compliance to Client procedures and external standards.
12. Support regulatory strategies and deliverables
13. Monitor the status of Economic Operator MDR regulatory compliance status.

Qualifications
Bachelor's degree is required, preferably in engineering or scientific related field.
1.Minimum of 5 years regulatory experience.
2.Experience with Class III medical devices. Relevant experience with animal and human origin materials preferred.
3.Experience in preparing EU submissions acc. to MDD requirements. Relevant experience with MDR preferred.
4.Ability to manage complex projects and timelines in matrix team environments.
5.Strong oral and written communication skills; technical writing skills.
6.Strong ability to problem solve and apply analytical thinking.
7.Ability to independently identify, assess and appropriately communicate risks.

Interview platform: phone, possible in person interview (if manager feels it is necessary)

About us:

DivIHN, the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.

Check out our careers page to see all of our job openings:


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Sr. Program Manager Quality/Clinical/Regulatory Affairs

Expired Job

Divihn Integration Inc