Remote Associate Director, Regulatory Affairs (MDR)

Summary

Join MCRA as a Manager, Regulatory Affairs to support regulatory strategy and submissions for the firm's clientele. Develop and execute regulatory services, including regulatory submissions, strategy, analysis & development, clinical evidence review, and more.

Requirements

• Bachelor’s degree in a scientific, engineering, or regulatory discipline; MS or PhD preferred
• Minimum five years of experience in Regulatory Affairs related to medical devices, drugs and/or biologics, developing regulatory deliverables and submissions
• An understanding of clinical research and data analysis is required
• 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 may advantageous
• 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
• Strong research, analytical, critical-thinking, and problem-solving skills
• Able to lead projects with support from MCRA staff and junior team members; takes initiative and ownership of results; demonstrates self-accountability
• Excellent organizational and prioritization skills with the ability to handle multiple tasks and meet deadlines
• PC/Technical skills - MS Office, Excel, Word, PowerPoint (Endnote experience is a plus)
• Must be punctual, polished and professional
• Effective interpersonal skills; shows confidence with subject matter and “calm under pressure” approach and style
• Strong client focus and relationship management skills
• Knowledge and experience utilizing research evidence and providing statistical analysis is advantageous

Responsibilities

• Develop and execute regulatory services for client companies
• Regulatory Submissions (e.g., Technical Documentation, CERs required; documentation for US, Canada and other regions is advantageous)
• Regulatory Strategy, Analysis & Development
• Clinical evidence review and sufficiency assessment
• Design & Review Pre-Clinical Testing
• Perform business development functions to secure new clients and projects
• Review and oversee technical writing and regulatory submission development by junior team members
• Communicate with regulatory bodies and clients with support of senior MCRA staff, as needed
• Work collaboratively with other MCRA departments, including clinical, RHEMA, and quality assurance
• Stay current on relevant European regulatory requirements
• Attending conferences and meetings as needed
• Complete other duties and projects as assigned