Precision Medicine Group

Director, CDx Strategy & IVD Regulatory Consulting

Remote, United States · Director

Sponsorship not specified$162k-$243kDetected 27 days ago

ComplianceAccount ManagementBusiness DevelopmentFDA RegulatoryMedical DevicesResearchLeadershipCommunicationPublic SpeakingRegulatory Affairs

About the role

Essential functions of the job include but are not limited to:
Apply quality systems expertise to guide clients towards successful readiness to market products in a regulated environment

Design strategic approaches to regulatory approvals, clearances, and post-market requirements to reflect the optimal business solutions for clients
Generate new business through your own network
Work in conjunction with the management team within the organization to design and develop customized, program recommendations and preliminary strategies for inclusion in client proposals
Work in partnership with the business development team to support the evaluation of requests for proposals and consider regulatory strategies that can be leveraged and regulatory approval timelines
Collaborate with the business development account management team to convert new business prospects into awarded and contracted business by participating in general capabilities presentations
Proactively identify client needs and develop solutions by gaining an understanding of the client's product, the brand objectives and other relevant industry trends
Support the development and refinement of the "go to market" strategy
Manage, motivate and develop staff to ensure a scalable model within the Regulatory practice as a whole
Support and contribute to Precision for Medicine culture

Minimum Required:
Bachelor's degree in Life Sciences or equivalent work experience
Minimum 5 years of applicable consulting experience with a focus in regulatory affairs
Ability to think outside of the box and solve difficult problems with effective solutions
Experience managing staff members and project teams
Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role.
Master's degree

Responsible for reviewing and providing information for program essential tools such as project plans, communication plans, etc.

Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role.

Review and direct the development of analytical and clinical protocols, technical reports and other company documents for use in regulatory submissions and in response to queries from regulatory agencies.

This listing is sourced directly from Precision Medicine Group's careers page and normalized into a canonical job model.