Job Category: Clinical Affairs
Job Number: 12222140
Women Back to Work (WBW) candidates will also be considered for this position.
Akraya is looking for a EU Medical Device Regulation (MDR) for one of our leading clients. To be considered, please apply or call Vaibhav at 408-512-2355.
We are an award-winning staffing firm that works with many leading technology-based companies around the world. The benefits offered to our employees include Health Insurance (Medical, Dental, and Vision), Cafeteria Plan (HSA, FSA, and dependent care), 401(k) (enrollment subject to eligibility), and Sick Pay (varies based on city and state laws). If this position is not quite what you’re looking for, visit akraya.com and submit a copy of your resume. We will get to work finding you a job that is a better match at one of our many amazing clients.
Primary Skills: Medical Device Regulatory Affairs, Creating Design Dossiers, Design Control, Clinical Affairs
Duration: 6 Months
Tax Term: W2 Only
- Provide technical writing support for conversion of existing Tech Files to an MDR compliant format and providing consultative advice on gap closure. Activities to include but not limited to.
- Interpret & assess domestic and global regulatory requirements and make recommendations based on the specific region to management to ensure new products, new features and capabilities are effectively and technical documentation is compliant to introduce to global markets.
- Develop approaches and methodologies based on established, changed and new legislation, regulation and guidance documentation.
- Specifically with the new EU MDR requirement.
- Stay abreast of all pertinent regulatory affairs issues. Interprets and applies FDA regulations to business practices and provides regulatory input, advice and guidance to the organization.
- Works out Regulatory scenarios to support decision making in line with technical documentation strategy.
- Other responsibilities include providing regulatory support for currently marketed products, including the review of engineering drawings, labeling, technical files, design history files, and engineering change orders.
- Active follow-up on the progression of technical documentation activities required to successfully and timely complete the deliverables.
Please apply directly with your update resume or call Vaibhav at 408-512-2355
- Medical Device Regulatory Affairs (5-10 years).
- Direct experience in creating Design Dossiers or Technical files for CE submission.
- Working knowledge of the EU Medical Device Regulation.
- Cross functional understanding of Design Control and Clinical Affairs as required to support RA submissions.
Akraya, Inc. is an award-winning staffing firm that works with many of the leading, technology-based companies around the world. We have been ranked as one of the “Best Staffing Firms to Temp for” by Staffing Industry Analysts on multiple occasions and are a preferred staffing vendor within numerous staffing programs. Please visit akraya.com to search through all of our current openings or to submit your resume to our recruiting team.