Freelance Technical Document Reviewing Specialist, Medical Devices (REF11437Y)

  • Siemensdamm 62, 13627 Berlin, Germany
  • Employees can work remotely
  • Contract

Company Description

ProPharma Group is an industry leading, single source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle for pharmaceutical, biotechnology, and medical device companies. Operating around the world with offices in Australia, Canada, Germany, Japan, the Netherlands, Sweden, United Kingdom, and the United States, ProPharma Group’s fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today’s dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes.

Job Description

At ProPharma Group we are currently looking for a Freelance Technical Document Reviewing Specialist - Medical Device, to be available as soon as possible for a full-time (40 hours/week) assignment.

The duration of the project is for 6 months, the work can be done 50% remote and 50% on-site in Bad Oeynhausen (near Hannover). In the first 3 weeks, the work will be performed full-time on-site. 

Responsibilities:

  • Support Design Control compliance within the phase gate product development process as specified for the business.
  • Lead, Review and Approval of Design History File (DHF) and Device Master Record (DMR) documents.
  • Lead Product Design Reviews as a Moderator for Design Input Approval, Design Readiness Approval and Final Design Approval.
  • Support Risk Management Activities, Usability Studies, Design Verification and Validation, Process Validation for products under design authority.
  • Ensure compliance with local site with Global SOPs through appropriate communication and knowledge of sound quality assurance principles.
  • Support QMS process, initiatives, and implementation in R&D projects.
  • Creating change requests for SOPs revisions as per latest standards.

Qualifications

  • ISO 13485, 21 CFR 820.30, EUMDR, ISO 14971 knowledge is must;
  • Relevant knowledge and experience (at least 5 years) in the medical device industry in multiple environments (MDR, IVDR, ISO13485, FDA 21 CFR part 820);
  • Project Management skills;
  • Customer oriented, passionate and able to effectively switch between different assignments;
  • Ambitious and enthusiastic relation builder with a quality driven mind-set;
  • Excellent proficiency in English language.

Additional Information

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***

 

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