Vacancy expired!
What will you do?• Prepare new product development documentation including study plans/reports, SOPs, and other technical documents• Proofread and ensure documents meets Quality and Regulatory requirements, guidelines, policies, and procedures• Facilitate and track the document routing and approval in collaboration with Core Team members and Document Management System change analysts• Actively participates with cross-functional new product development teams to ensure documents are in compliance with design controls per ISO 13485 and FDA QSR.• Generate templates and guidance documents in partnership with Regulatory and Clinical Affairs, Quality/Design Compliance and other stakeholders• Standardize and streamline documents and documentation system in coordination with R&D team and managers• Aid in preparation of documents for regulatory submission• Proactively solicit information from other experts within the company as needed (e.g. R&D, Manufacturing, QA, QC, Legal)
How will you get here?Education:• Master's Degree with 1-2 years writing experience.• Preferred BA/BS Degree, 5+ years/ MS Degree, 3+ years of industry experienceExperience:• At least 2 years prior experience writing and coordinating SOP and/or technical documents required.• Ability to work collaboratively in cross functional teams and provide pro-active communication is required.• Understanding of Quality Systems Regulations and Good Documentation Practice• Familiarity with phase-gate product development process• Familiarity with the process of obtaining CE-IVD and/or FDA clearance/approval of In Vitro Diagnostic (IVD) products• Experienced using electronic Document Management Systems• Highly skilled at using Microsoft Office (Word/Excel), able to create and manage styles, permissions, macros etc.• Experience in a lab setting in life sciences and/or an understanding of molecular biology and associated techniques(Preferred):• Experience in Quality Assurance is a plus.• Preferred BA/BS Degree, 5+ years/ MS Degree, 3+ years of industry experienceKnowledge, Skills, Abilities:• Extremely organized and detail-oriented professional with excellent proofreading and editing skills• Ability to complete tasks in a fast-paced, cross functional environment with multiple concurrent projects• Driven to deliver quality results on time and in a highly ethical and professional manner• Demonstrated resourcefulness, strategic and analytical thinking, and directed toward achieving objective• Must be tolerant to change, ready to take on new challenges and open to learning new skills• Science background with experience in Research and Development would be a plus. Need a person with a goodunderstanding of the lab, experiments, product development.• Experience and knowledge in the Regulatory bodies is good. Remote position but must be local as may be required to be onsite from time to time. Shift Times/Days: Mon thru Friday - 8am-5pmPay rate: $35.00 hourly pay rate.Interview Process: Phone interview RegardsBhaskar Dasegowda Scottsdale, AZ P: +1 (310)-526-8106bhaskar.dasegowda@encora.comBhaskar.encora@gmail.com encora.com- ID: #43171019
- State: Texas Austin 73301 Austin USA
- City: Austin
- Salary: $0 - $35
- Job type: Contract
- Showed: 2022-06-17
- Deadline: 2022-08-09
- Category: Writing/editing