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EU-Medical Device Regulation (MDR) Specialist
Bridgewater, NJ, US
Scientific
Bachelors Degree
Full Time, Temporary
Experienced (Non-Manager)
On-site
Medical Devices and Supplies
First Shift (Day)
Bridgewater, NJ, US
Experienced (Non-Manager)
Full Time, Temporary
Medical Devices and Supplies
On-site
Scientific
Bachelors Degree
First Shift (Day)
Job details
EU-Medical Device Regulation (MDR) Specialist
Kelly® Science & Clinical is seeking an EU-MDR Specialist for our client in Bridgewater, NJ. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.
Schedule: REMOTE Monday through Friday
Must be available to work Eastern Time Zone
Pay $48-50 an hour
Length of assignment: through 2025 may extend into 2026
Responsibilities:
- Contribute to the implementation of EU-Medical Device Regulation (MDR) and global regulation activities as assigned in the Global Device Complaint Management (GDCM) department.
- Development and update of departmental procedures, PMS documents as part of the Technical File (e.g. PMS Report, PSUR, PMS Plan
- Prepare Post Market Surveillance (PMS) documents as part of the Technical File (e.g. PMS report, PSUR, PMS Plan) and other ad-hoc PMS aggregate reports.
- Ensure that PMS documents for Technical Files meet the EU MDR requirements
- Support department projects and /or participate in cross functional projects as required
- Support complaint handling trending activities
- Support Audits (Internal and Notified Body) and Inspections related to Post-Market Surveillance
- Generate periodic reports as requested per government agencies and /or Notified Bodies.
- Act as lead in the global development of departmental procedural documents (SOPs WIs) including but limited to initiating the document change request process for new/updated departmental procedures and processes.
- Liaise with internal functions (Quality, Regulatory, Medical Affairs, Clinical) to gather critical input into procedural documents.
- Strong skills in working and leading change within a global team.
- Develop and maintain an understanding and competence in all company SOPs, global regulations and Local Laws, GCP, ICH as well as ethical standards ensuring alignment with global requirements.
- Represent GDCM and the company in an ethical and positive manner
- Requirements:
- Bachelor’s degree in a scientific or business-related discipline and at least 3-5 years of medical device post-market surveillance and/or pharmacovigilance experience
- Good understanding of medical device industry principles and regulations related to EU MDR, vigilance and post-market surveillance
- Experience in development and implementation of company Standard Operating Procedures
- Technical writing and presentation skill
- Understanding of statistics and data analytics
- Strong organizational skills, detail orientated, ability to adapt in a fast paced constantly changing environment
- Ability to work independently and within a global team
- High level of computer proficiency (Microsoft Word, Excel, PowerPoint and Outlook)
- Clear, effective written and verbal communication skills
- Good interpersonal and leadership skills (i.e., team player) Travel when required ~ 10%
What happens next
Once you apply, you’ll proceed to the next steps if your skills and experience look like a good fit. But don’t worry—even if this position doesn’t work out, you’re still in our network. That means all of our recruiters will have access to your profile, expanding your opportunities even more.
Helping you discover what’s next in your career is what we’re all about,
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