Manager, Regulatory Affairs

Organization: 
QIAGEN
Job Location: 
Gaithersburg, MD
Job Description: 

The Manager of Regulatory Affairs will develop regulatory strategies for new and modified QIAGEN in vitro diagnostic (IVD) products.

• Prepare regulatory submissions for US and Health Canada approvals for QIAGEN IVD products that include RT-PCR test kits for infectious disease viral markers. Other products include reagents and instrumentation for nucleic acid extraction from biological samples that are linked to downstream IVD test applications
• Review product labeling and promotional literature for regulatory compliance
• Research and interpret regulations, guidelines and precedents to support interdepartmental project teams in developing strategies, policies and procedures that ensure regulatory compliance with FDA, Health Canada and other regulatory agencies in the least burdensome manner
• Interface with regulatory agencies for inquiries and issues
• Review and prepare clinical reports, R&D protocols and technical reports and other company documents (including labeling and marketing materials, when applicable) for use in regulatory submissions and in response to queries from the FDA and Health Canada
• Work closely with Customer Care/Technical Services to ensure quality of information and adequate processing of complaints and establish MDR reporting measures and continuous improvement activities
• Develop regulatory process SOPs relevant for registration of IVD products or other regulatory aspects
• Responsible for ensuring on-going compliance to applicable quality and EHS regulations and standards (e.g., ISO, US FDA, MDD, IVDD, EU-PSHA, OSHA, etc.).

Requirements: 

• Minimum Bachelor’s Degree in a scientific discipline.
• Molecular biology or clinical laboratory experience would be a strong asset in the position.
• RAC certification preferred, but not required.
• At least 4 years experience in the medical device, pharmaceutical or biologics industry, with at least 2 years experience in Regulatory Affairs preparing 510(k) and/or PMA submissions, preferably in the area of IVDs .
• Demonstrated strong attention to detail, as well as the ability to work under pressure to meet project deadlines.
• Demonstrated organizational, planning and prioritizing abilities are required, as well as strong technical writing ability.
• Ability to work on complex problems and exercise sound science-based decision making in developing regulatory strategies and solutions to regulatory problems.
• Knowledge of German would be very helpful, but not required.
• Able to communicate effectively with employees at all levels of the QIAGEN organization as well as with key individuals outside the organization. These outside contacts may include FDA reviewers, consultants, and representatives from clinical sites or other IVD or pharmaceutical companies.
• May supervise employees.
• Moderate travel required.
• Must have strong interpersonal and communication skills with strong English language ability
• Thrive in a fast paced work environment, while possessing the ability to quickly change priorities and perform multiple tasks simultaneously