Associate Regulatory Affairs Director, Spine

Overview

The Associate Director, Regulatory Affairs, Spine will be a critical team member supporting regulatory strategy and submissions for the firm’s clientele. The primary roles and responsibilities include managing the development of regulatory submissions, development of overall regulatory strategy, and communicating with regulatory bodies and clients. The projects may be for companies in MCRA therapeutic areas, other MCRA areas of regulatory and scientific expertise, and/or other growing therapeutic concentrations of MCRA. The Associate Director will also manage various personnel during various projects, as well as act as a mentor and trainer for junior employees. 

Responsibilities and Duties

• 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 junior members of MCRA’s regulatory department.
• Perform business development functions to secure new clients and projects.
• Work directly with client companies and/or regulatory bodies without senior MCRA staff oversight.
• Provide project leadership while maintaining sole relationship with client companies.
• Work collaboratively with other MCRA departments, including clinical, RHEMA, and quality assurance.
• Stay current on relevant medical device regulatory requirements.
• Attend conferences and meetings as needed.
• Complete other duties and projects as assigned.

Required Knowledge, Skills, and Experience

• Education: Bachelor’s degree in a scientific, engineering, or regulatory discipline; MS or PhD preferred.
• Certification/Licensure: Not applicable.
• Experience: Minimum seven years of experience in Regulatory Affairs related to development of medical devices, drugs and/or biologics, developing regulatory deliverables and submissions. Work experience must include managing regulatory submissions.
• Other:
  • 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.
  • International regulatory experience including developing Technical Documentation and CERs is advantageous.
  • 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.
  • Strong research, analytical, critical-thinking and problem-solving skills.
  • Strong professionalism with customer relations and managing client relationships.
  • Ability to lead junior staff effectively and mentor junior team members.
  • Able to lead multiple projects without support; 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.
  • Knowledge and experience utilizing research evidence and providing statistical analysis is advantageous.