Medical Writer
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Job Location:
Monthly Salary:
Posted on:
18 hours ago
Vacancies:
1 Vacancy
Job Summary
Are you passionate about medical writing and ensuring regulatory compliance in the medical device industry Do you want to play a key role in creating clinical documentation that supports patient safety and innovation
As part of our Clinical Affairs team you will contribute to the development and maintenance of clinical evaluations and PostMarket Clinical Followup (PMCF) documentation for our hearing solutions portfolio. You will work closely with internal stakeholders and external authorities to ensure compliance with EU MDR and other regulatory requirements.
As a Medical Writer youll combine scientific expertise with regulatory knowledge delivering highquality clinical documentation and acting as a trusted advisor within the organization.
Working with us you will receive:
- fulltime work agreement in an international organization
- possibilities for learning and development opportunities adapted to your needs and supporting your growth
- hybrid work model combining remote work opportunities with work in an office in the City Center
- flexible working hours
- benefits package including social benefits (private medical health care insurance sport card etc.)
- Scandinavian culture we are informal and care about equality independence open dialog and worklife balance
What tasks are waiting for you
- Write and maintain clinical evaluations and PMCF documents in compliance with EU MDR and internal standards
- Monitor evaluate and implement regulatory requirements related to Clinical Affairs including Clinical Evaluation and PMCF
- Ensure the level of clinical evidence required to achieve regulatory compliance for assigned products
- Communicate clinical evidence needs and results to internal stakeholders across the organization
- Represent Clinical Affairs towards external parties such as competent authorities
- Make content decisions on clinical evaluations and PMCF documents
- Act as a Subject Matter Expert within the Clinical Affairs area
- Make projectrelated decisions for Clinical Affairs project
Apply today if:
- you hold a higher degree within audiology health technology/science or a similar field
- you have documented professional experience working with hearing aids or other medical devices (EU MDR class IIa or higher)
- you possess knowledge of and preferably experience with:
research methodology
information management
regulatory requirements
medical writing
preparing clinical evaluation plans and reports for at least EU MDR class IIa (active) medical devices
device technology and application
diagnosis and treatment options for hearing conditions covered by the devices being evaluated - you have excellent English skills both written and spoken
- in your daytoday tasks you keep attention to details
If you have any questions contact the recruiter: Jakub ()
Furthermore we would like to inform you that the company has an internal reporting procedure which is available at:demantcompliance - Make a report ()
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Key Skills
- Clinical Research
- Adobe Acrobat
- FDA Regulations
- Technical Writing
- Biotechnology
- Clinical Development
- Clinical Trials
- Microsoft Powerpoint
- Research Experience
- Document Management Systems
- Word Processing
- Writing Skills
About Company
Leading in hearing healthcare Demant is the only company in the world that covers all areas of hearing healthcare, from hearing devices and hearing implants to diagnostic instruments and professional hearing care, and we harvest significant synergies from this unique position and exp ... View more
