Director, Digital Health Regulatory Affairs

MCRA is a leading medical device advisory firm and clinical research organization (CRO). MCRA's value contribution rests within its industry experience at integrating five business value creators-regulatory, clinical research, reimbursement, healthcare compliance, and quality assurance-to provide a dynamic, market-leading effort from concept to commercialization. MCRA's integrated application of these key value-creating functions provides unparalleled expertise for its clients. MCRA has offices in Washington, DC, Manchester, CT, New York, NY, and a global presence in Japan and Europe and serves more than 1100 clients globally. Its core focus areas of therapeutic experience include orthopedics, spine, cardiovascular, neurology, Digital Health, diagnostic imaging, wound care, dental, general healthcare, robotics, and in vitro diagnostic (IVD) devices.

The Director, Regulatory Affairs will be a critical team member supporting regulatory strategy and submissions for the firm's Digital Health 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.  Director 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 (510(k), IDE, PMA, De Novos, BLA, & IND)
• 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.
• Work directly with client companies and/or FDA without Director or direct report oversight.
• Provide project leadership while maintain sole relationship with client companies.
• Work collaboratively with other MCRA departments, including clinical, reimbursement, and quality assurance.
• Work with other department heads and the general manager to guide progress and development of the regulatory department and company.

Required Knowledge, Skills, and Experience

• Education: Bachelor's degree in a scientific discipline; Master of Science or PhD preferred.
• Minimum of 10 years of experience in Regulatory Affairs related to development of medical devices/technologies, biologics and/or pharmaceuticals.
• Experience with leadership responsibilities for numerous projects and functioning as primary contact for regulatory bodies (i.e., FDA) and clients.
• 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 and verbal communication and presentation skills.
• Possesses engineering and/or biological background to assist with pre-clinical and clinical strategies and is able to effectively communicate these strategies to internal team members and clients.
• Possesses domain specific regulatory expertise.
• Experience developing and/or reviewing regulatory submissions to the US FDA and/or experience with international Regulatory Affairs and the regulatory bodies governing them.
• Strong research, analytical and problem-solving skills.
• 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.
• Knowledge and experience utilizing research and providing statistical analysis.
• Effective interpersonal skills: shows confidence with subject matter and "calm under pressure" approach and style.
• Experience working with C-Level, management, and company executives. 
• Ability to lead a team and mentor junior Regulatory Team members.
• Strong professionalism with customer relations and managing client relationships.

NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as to meet the ongoing needs of the organization.