Director, Regulatory Affairs, EMCRobotics

MCRA is part of IQVIA MedTech. As a trusted CRO and advisory partner IQVIA MedTech and MCRA deliver integrated lifecycle solutions for the medical device and diagnostics industry. Together we support innovation from concept to commercialization offering expertise in regulatory strategy clinical trial design and execution market access and post-market optimization. Our teams combine deep therapeutic knowledge with advanced data and technology to help clients make smarter decisions and thrive in the market. Join our team to help shape the future of MedTech.

Overview

The Director Regulatory Affairs EMC/Robotics will be a critical team member supporting regulatory strategy and submissions for Robotics and Electromagnetic Compatibility (EMC) clientele. The primary roles and responsibilities include managing the development of regulatory submissions development of overall regulatory strategy communicating with regulatory bodies and clients. The 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 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.

Required Knowledge Skills and Experience

• Education: Bachelors degree in a scientific engineering or regulatory discipline; MS or PhD preferred.

• Experience: Minimum ten 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 project management and/or managerial experience.

• Required: Experience in Robotics and Electromagnetic Compatibility (EMC)
• Exposure to navigation systems or navigation instruments within robotics
• Experience with a robotics start-up is a plus

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.

• Understanding of your teams 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 as required.

• 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.

• Knowledge and experience utilizing research evidence and providing statistical analysis is advantageous.

IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin disability status as a protected veteran or any other status protected by applicable law. potential base pay range for this role when annualized is $107800.00 - $300400.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge skills education and experience; location; and/or schedule (full or part-time). Dependent on the position offered incentive plans bonuses and/or other forms of compensation may be offered in addition to a range of health and welfare and/or other benefits.