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Clinical Supply Chain Planner

Company: Real Staffing
Location: Cambridge
Posted on: September 23, 2022

Job Description:

Sr. Regulatory Affairs Specialist (RE-33928771) Job Description:
Sr. Regulatory Affairs Spec.- Medical Device
Location: Remote
Contract: 12 Months + Potential extension or Full time opportunity
Compensation: Rate depends on experience
Benefits: Real Staffing offers medical, dental, vision, 401K
**W2 Employment Opportunities - Unable to offer sponsorship**Description

  • Quick ability to learn multiple systems, products, cross functional teams and the associated regulatory requirements and quality management system.
    2. High attention to detail and accuracy; ability to write submissions and deficiency responses.
    3. Proactive; able to work independently, reach out to cross-functional team to obtain information or resolve challenges.This position will be responsible to work cross-functionally with the Pelvic Health EU MDR team to write the EU MDR technical documentation, submit to the notified body, lead deficiency responses, obtain notified body approval, and work within quality management system to release the product.Additional regulatory work may be assigned (tech file updates, tender requests, change assessments and change notifications, etc.)

    Education Required: Bachelors degree in related field. Experience with notified body TUV, EU MDR class IIa, IIb, III, Implantable, and assessing changes would be beneficial.Skills:
    Experience working on EU MDR files or experience with the notified body TUV preferred.Must be self-motivated, proactive, willing to learn several systems, processes, and willing to network with subject matter experts for answers.Willing to lead the submission writing and deficiency response process.EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Keywords: Real Staffing, Cambridge , Clinical Supply Chain Planner, Professions , Cambridge, Massachusetts

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