Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
Responsibilities:
Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
Leads or compiles all materials required in submissions, license renewal and annual registrations.
Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
Monitors and improves tracking / control systems.
Keeps abreast of regulatory procedures and changes.
May direct interaction with regulatory agencies on defined matters.
Recommends strategies for earliest possible approvals of clinical trials applications.
Requirements:
Candidate is required to work on site in Boulder, CO or Minneapolis, MN at least 3 days per week.
Experience with US and EU change assessments.
Experience reviewing and support MDR Clinical Evaluation documentation as a Regulatory stakeholder (not necessarily as an author).
Willingness to be adaptive, collaborative, and supportive of the Regulatory team.
Bachelor’s with 4+ years’ experience in RA, advanced degree with 2+ years’ experience in RA.
Strong experience with change assessments for EU/US marketed products.
Strong organizational skills to manage multiple projects simultaneously under limited supervision.
Analytical thinking to identify potential regulatory issues and develop effective solutions.
Demonstrated excellent organizational skills.
Demonstrated technical writing skills.
Excellent attention to detail.
Excellent communication skills.
Experience as regulatory lead in core teams for sustaining and development projects.
Expert proficiency in Microsoft Office suite, including Word and Excel.
Proficient at managing multiple projects at once.
Regulatory assessment of change orders emphasis on US and EU.
Documentation Practices.
RAPS Regulatory Affairs Certification (RAC).