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Senior Regulatory Affairs Specialist (Science & Biotech)
Highlands Ranch, CO 80130
Recruited by: Jan Sather | Recruiter | Career Marketing Associates See all my Jobs

  • Hiring Company: Top Talent Search, Inc.
  • Industry: Science & Biotech
  • Compensation: Salary: 100K to 125K
  • Expires: Dec 10, 2020
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Interested?    Give us a call    303-961-6934

Job Description

Europe is switching from Medical device regulations (MDR) to medical device usability (MDU, human factors and usability)

The Senior Regulatory Affairs Specialist must be able to demonstrate the following:
• Develop strategies to help client companies obtain for 510K submissions to obtain FDA approval
• Manage multiple projects and prioritize tasks on a day by day basis in order to meet project schedules
• Use strong critical thinking skills to navigate the gray and to reach appropriate conclusions
• Work effectively with customers in many functional areas
• Apply excellent written and verbal communication skills to communicate internally and externally
• Have a continuous improvement mindset, always looking for ways to improve the way we do our jobs

Responsibilities Include:
• Establish and implement regulatory strategies for new technologies and product modifications, considering both domestic and international regulations.
• Prepare 510(k) submissions and technical documents to support the CE mark and other international submissions
• Provide regulatory affairs support to design teams and sustaining engineering; this includes input into bench and pre- clinical test requirements
• Establish and maintain a professional and credible image with FDA, notified bodies, and other regulatory agencies
• Evaluate information on competitive technologies as needed to identify appropriate predicate or comparable devices to be ncluded in 510(k)s and clinical evaluation reports.
• Design History File documentation and adherence to FDA/QSR design control requirements.
• Interface with engineering, clinical, regulatory, sales, marketing, and other functions as needed to fulfill responsibilities
• Review and approve marketing collateral
• Maintain current regulatory knowledge of domestic and international regulations, guidelines, and standards
• Create or revise departmental procedures to improve operations or to reflect changing regulatory requirements
• Participate in internal and external audits as needed
• Support international product registrations as needed

Must Have: Minimum Qualifications

• Bachelor’s in scientific or engineering discipline
• Minimum 8 years of experience in medical device regulatory affairs (could come from pharma)
• Proficient with MS Office software
• Demonstrated technical writing skills

Nice to Have
• Advanced degree and/or Regulatory Affairs Certification from RAPS
• Demonstrated successful history of submissions to FDA and notified bodies
• Working knowledge of IEC 60601-series standards
• Prior experience with software-driven devices
Interested?    Give us a call    303-961-6934