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IQVIA · 2 days ago

Director, Regulatory Affairs, EMC/Robotics

Washington, DC

Full-time

Onsite

Director/Executive

$108K/yr - $300K/yr

10+ years exp

IQVIA is a leading global provider of clinical research services and healthcare intelligence. The Director, Regulatory Affairs, EMC/Robotics will support regulatory strategy and submissions for Robotics and Electromagnetic Compatibility (EMC) clientele, manage regulatory submissions, and mentor junior employees.

AnalyticsHealth CareLife Science

Responsibilities

Develop and execute regulatory services for client companies, including however not limited to:

Regulatory Submissions (e.g., 510(k), IDE, PMA, IND, BLA, & IND, Technical Documentation, STED, CERs)

Regulatory Strategy, Analysis & Development

Design, Review & Implement Pre-Clinical Testing

Manage Regulatory Affairs staff, facilitate professional development and ensure regulatory projects are completed in an accurate and timely manner

Lead/manage business development functions to secure new clients and projects

Develop project and departmental budgets and timelines, as required

Work directly with client companies and/or regulatory bodies without oversight

Provide project leadership while maintaining sole relationship with client companies

Lead people development projects, working alongside team managers, as required

Work collaboratively with other MCRA departments, including clinical, RHEMA, and quality assurance

Work with other department heads and executive management to guide progress and development of the regulatory department and company, as required

Qualification

Regulatory AffairsRoboticsElectromagnetic Compatibility (EMC)Regulatory SubmissionsClinical ResearchData AnalysisProject ManagementStatistical AnalysisMS OfficeTechnical WritingCommunication SkillsProblem-SolvingInterpersonal SkillsOrganizational SkillsAttention to DetailTeam Leadership

Required

Bachelor's degree in a scientific, engineering, or regulatory discipline

Minimum ten years of experience in Regulatory Affairs related to development of medical devices, drugs and/or biologics, developing regulatory deliverables and submissions

Experience in Robotics and Electromagnetic Compatibility (EMC)

An understanding of clinical research and data analysis

Possesses US and/or International regulatory experience/fluency with regulations (e.g., FDA, Notified Body, ISO 13485)

Domain-specific regulatory expertise in a therapeutic area or other MCRA areas of regulatory and scientific expertise

Understanding of your team's regulatory landscape, including the breadth of services, how they interact, and how data flows between deliverables

Strong attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors

Possesses strong written, including medical/technical writing, and verbal communication and presentation skills

Possesses an understanding of engineering and a biological background to assist with pre-clinical and clinical strategies and is able to effectively communicate these strategies to internal team members and clients

Able to creatively think through potential solutions and put the solution skillfully on paper

Strong research, analytical, critical-thinking and problem-solving skills

Strong professionalism with customer relations and managing client relationships

Ability to lead a team effectively, mentor junior team members, and is accountable for team reaching target utilization

Able to lead multiple projects with competing deadlines; takes initiative and ownership of results; demonstrates a high-level of self-accountability

Excellent organizational and prioritization skills with the ability to handle multiple tasks and meet deadlines while working independently

PC/Technical skills- MS Office, Excel, Word, PowerPoint

Must be punctual, polished, and professional

Effective interpersonal skills: shows confidence with subject matter and 'calm under pressure' approach and style