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Sr R D Engineer Jobs in Georgia (NOW HIRING)

Griffith Foods

Senior Project Engineer

Lithonia, GA

$90K - $117K/yr

Onsite in Lithonia, GA S alary R ange : $ 10 3 ,000 - $140,000/year plus bonus Griffith Foods is ... D, Voluntary Life Insurance, Short Term & Long Term Disability, 401(k) Plan with Company Match ...

Bright Mind Solutions LLC

Sr. Test Engineer

Atlanta, GA · On-site

$40 - $45/hr

Sr. Test Engineer Atlanta, GA F2F R Top 5 required skillsets: * Expertise in functional testing and test automation * Proficiency in Test Driven Development (TDD) and Behavior Driven Development (BDD ...

RWDC Industries

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Automation Controls Engineer

Athens, GA · On-site

$110K - $140K/yr

Leads R & D activities concerned with integration and testing of electronic/mechanical components ... BSEE, BSCS or other engineering degree or related discipline * 10+ years of experience in ...

Urgent

Belcan

Senior Electrical Design Engineer

Atlanta, GA · On-site

$50.38/hr

Job Title: Sr. Electrical Design Engineer II Location: Atlanta, GA Zip Code: 30309 Start Date ... Engineer | Facilities Electrical Enginee r Belcan is an equal opportunity employer. Your ...

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Sr R D Engineer information

What is the difference between Sr R D Engineer vs R D Engineer?

AspectSr R D EngineerR D Engineer
QualificationsBachelor's/Master's in Engineering, relevant certificationsBachelor's/Master's in Engineering, relevant certifications
Work EnvironmentLeading projects, mentoring juniors, cross-functional collaborationExecuting research tasks, supporting project development
ResponsibilitiesDesign innovation, project oversight, process improvementsResearch, testing, data collection, prototype development
Industry UsageResearch labs, R&D departments in tech, manufacturing, pharmaResearch teams, product development units in similar sectors

The main difference between a Sr R D Engineer and an R D Engineer lies in experience, responsibilities, and leadership. Sr R D Engineers typically oversee projects, mentor team members, and drive innovation, while R D Engineers focus on executing research tasks and supporting project goals. Both roles require similar educational backgrounds and work in comparable environments, but the senior role involves more strategic and managerial duties.

What cities in Georgia are hiring for Sr R D Engineer jobs?

Cities in Georgia with the most Sr R D Engineer job openings:

Sr R D Engineer jobs near you

Senior Principal Regulatory Affairs Specialist - Transfusion

Norcross, GA • On-site

UNAVAILABLE
See more jobs at UNAVAILABLEexternal

$150 - $200/hr

Other

Posted 3 days ago

New

Job description

Overview

Job Summary

As a Senior Principal Regulatory Affairs Specialist, you will perform regulatory affairs and quality system support activities associated with the manufacture and distribution of the Werfen product lines for U.S., Canada, and European Union.

Responsibilities

Key Accountabilities

  • Coordinates preparation, review and submission of product applications (510(k), BLA, Medical Device Licence Applications/Amendments, and Technical Documentation
  • Prepares and maintains Technical Files (Technical Documentation)
  • Reviews and approves quality system documents to determine compliance with SOPs, quality system and regulatory compliance, and industry standards
  • Reviews and approves significant changes (e.g. facility, product, process and labeling changes) for regulatory impact and domestic and international reporting requirements
  • Maintain regulatory product files of information submitted in support of domestic and international registrations
  • Coordinates field action and vigilance activities for Werfen product lines and notifies appropriate regulatory agencies, affiliates and distributors
  • Performs tasks and functions associated with product recalls/field corrections including preparing customer notifications, government submissions, status reports and recall effectiveness checks
  • Evaluates complaint and internal deviation report data to determine the need for Medical Device Reporting, field action or Biological Product Deviation reporting
  • Maintains compliance with Medical Device Listing requirements for Werfen products
  • Recognizes and elevates critical regulatory/compliance issues to RA management
  • Assists with the administration of regulatory and third-party inspections.
  • Performs other duties as assigned

Networking/Key Relationships

  • Works closely with other R & D staff members, quality control, quality assurance, customer service, shipping, sales and marketing staff.
Qualifications

Minimum Knowledge & Experience required for the position:

Education:

  • Bachelor’s degree in science, engineering or related field required.
  • RAPS certification and membership, preferred

Experience:

  • Minimum of eight (8) years of experience in the US, EU, and international regulatory affairs within the medical device industry required.
  • Thorough knowledge of the product development and design control process.

Skills & Capabilities:

  • Sophisticated knowledge of and experience with FDA medical device and/or biologics regula-tions and guidance, Regulation (EU) 2017/745 or 2017/746 (IVDR) and guidance, Good Clinical Practices guidance, ISO 1348:2016 Quality System standards, ISO 14971:2019 Risk Manage-ment, and other applicable US and international regulations, guidances, and standards required.
  • Works precisely according to procedures, rules and regulations, has a passion for continuous improvement and quality.
  • Demonstrates the highest ethical standards, actively promotes trust, respect and integrity in all dealings both inside and outside the Company.

Travel Requirements:

10%

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact NAtalentacquisition@werfen.com for assistance.

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.

www.werfen.com

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