To discuss more about this job opportunity, please reach out to Himanshu Kumar Singh(LinkedIn URL - https://www.linkedin.com/in/himanshu-kumar-singh-57b782258/), email your updated resume at Email - himanshu.ksingh@collabera.com or give me a call at (425) 403-0902. Thank you!

Pay Range: $50 - $57/hour 

Position Details:

• Industry: Medical Device
• Duration: 9 months (possible extensions)

• Applies advanced regulatory expertise to guide cross-functional partners and demonstrates strategic thinking and creativity in support of programs.

• Provides regulatory affairs project management for various areas, to include regulatory submissions for new products, label/advertising/promotional review, and other regulatory compliance activities.
• In collaboration with Regulatory leadership, develops and implements regulatory strategies that will ensure earliest possible introduction of new product(s) into domestic and international markets.
• Co-ordinates preparation of well organized, complete and scientifically sound regulatory submissions.
• Interfaces directly with various regulatory agencies, as required, to facilitate the timely review and approval of regulatory applications.
• Responsible for filing necessary applications and handling government interactions pertaining to the regulation process for products requiring regulatory approval.
• Provides guidance on regulatory requirements and strategies to product development project teams.
• Recommends, interprets and implements companywide policies and procedures to accomplish assignments and resolves a broad range of issues and problems.
• Exercises judgement within generally defined practices and departmental standard operating procedures. Maintain expert working knowledge of relevant laws, regulations and enforcement decisions.
• Knowledge of EU MDR requirements and other applicable EU regulations as they relate to Class III implantable medical devices.
• Authors and submits clinical trial applications under EUMDR and applications for CE mark. Proven successful track record of authoring/submission/approval of Class III implantable devices in EU.
• Authors and submits IDE and PMA submissions, as well as supplements (5-Day Notice, 30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports etc.).
• Knowledge of FDA guidance documents and CFR regulations.
• Working knowledge of regulatory requirements for Japan, Canada, and other countries is advantageous.
• Reviews/approves engineering study protocols/reports and validation study protocols/reports.
• Reviews and approves manufacturing changes for Class III implantable medical devices.
  Relies on extensive experience and judgment to plan and accomplish goals.
• Performs a variety of tasks. Reports to head of a unit/department.

• Bachelor's degree (preferably in medical, science or engineering related discipline) or equivalent combination of education and work experience.
• Preferably 8 years experience in the medical device industry, with 5 of those years related to the preparation of FDA and EU MDR submissions for Class III medical devices.
• Ability to work effectively on project teams. Ability to leverage and/or engage others to accomplish projects
• Must be able to juggle multiple and competing priorities.
• Strong written, verbal, presentation, and organizational skills.
• Working knowledge of QSR, ISO, and EN standards.
• Strong organizational skills and attention to detail.
• Experience reviewing manufacturing operations and changes (change control).
• Solid communication skills and ability to communicate at all levels.
• Ability to think laterally and adapt to change.