Regulatory Affairs Specialist II/Senior 2017-039 - Boulder, CO | Biospace
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Regulatory Affairs Specialist II/Senior 2017-039

Somalogic, Inc.

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Location:
Boulder, CO
Posted Date:
7/27/2017
Position Type:
Full time
Job Code:
98657071
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Regulatory Affairs,

Job Description


SomaLogic, Inc.

Regulatory Affairs Specialist II/Senior 2017-039



SomaLogic is a 200-person privately owned biotechnology company that delivers precise and personalized health insights using its proprietary technology, which measures changes in thousands of different proteins in blood and other sample types. We are a dedicated team of science-based colleagues working to maximize health and wellness for people around the world. We are seeking a Regulatory Affairs professional with the expertise and knowledge to help in meeting our company goals and objectives.

The Regulatory Affairs Specialist will be a key member of the organizational unit responsible for compliance with the continuously changing regulatory landscape in the US and international markets. The regulatory team supports a broad range of different markets and regulatory requirements, from IVD (US and International) to CLIA testing and Lab Developed Tests (LDT) and other markets for health and wellness insights. The Regulatory Affairs Specialist will be a member of the company’s overall compliance efforts and may be asked to address new and developing compliance requirements. This position supports product development/changes, regulatory submissions, and required registrations as needed. Level is commensurate with experience.

Key Job Responsibilities

  • Maintain current regulatory knowledge and share within organization as needed
  • Provide regulatory and quality guidance on requirements and compliance documentation in support of design teams
  • Lead regulatory submissions and registrations as needed (510(k), CE Technical Files, pre-IDE, de novo, etc.)
  • Support product/process improvement activities as part of the overall quality system effort
  • Conduct review of local regulations and industry standards to advise on best practices for compliance
  • Assist with the company training program
  • Identify appropriate regulatory submission pathways and product classifications
  • Support certification and audit programs as needed, including the company’s internal audit program
  • Review company documentation for compliance with applicable regulatory requirements including marketing and promotional materials, product labeling, and external communications
  • Maintain regulatory registrations through appropriate updates and ensuring fees are paid

Education

  • Minimum of a Bachelor's Degree in Scientific/Technical field (i.e. Chemistry, Biology, Biochemistry, Molecular Biology) or equivalent work experience; prefer BS with 6 years or MS with 4 years of experience
  • Regulatory Affairs Certification (RAC) from RAPS desired

Skills and experience

  • Greater than 3 years of experience in Regulatory Affairs
  • Experience with and clear understanding of 21 CFR Part 820 and the new EU IVD regulations (medical devices) is required
  • Knowledge and experience in compliance with IEC and ISO standards is required
  • Must be able to work effectively in a fast paced, cross-functional team oriented environment
  • Ability to maintain multiple projects and meet timelines
  • Ability to work independently with minimal supervision
  • Experience in the development, qualification, and validation of software is a plus
  • Understanding of the Shield Data Privacy Act and related data privacy and control regulations such as HIPAA and HITECH is a plus
  • Experience with CLIA regulations and compliance is desired
  • Understanding of import/export requirements from FDA and Department of Commerce is a plus
  • Proficient using Word and Excel applications and Windows operating system and demonstrated ability with database applications
  • Detailed oriented
  • Statistical and/or risk management training

Work Environment

Work is in typical office environment but may require occasional work in a typical laboratory environment with personal protective equipment use required. Position may require up to 10% travel (US and international).

PI98657071

Requirements