Associate Director, Cardiovascular Regulatory Affairs (Electrophysiology and Digital Health)

, , Poland

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.

MCRA is seeking an Associate Director/Director, Cardiovascular Regulatory Affairs to be a critical team member supporting regulatory strategy and submissions for the firm’s cardiac electrophysiology 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 Associate Director/Director will also manage various personnel during various projects, as well as act as a mentor and trainer for junior employees.

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

Regulatory Submissions (510(k), IDE, PMA, IND, BLA, & IND)

Regulatory Strategy, Analysis & Development

Design, Review & Implement Analytical and Clinical Testing

Manage junior members of MCRA’s regulatory department.

Assist in business development functions (i.e., provide insight on BD calls, bid defenses, etc.) to secure new clients and projects.

Work directly with client companies and/or FDA without Director or other leadership oversight.

Provide project leadership while maintaining sole relationship with client companies.

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

Work with other regulatory leadership to help guide the progress and development of the spine team and the regulatory department.

Technical writing and review of documents and deliverables.

Represent MCRA at conferences and meetings as needed.

Complete other duties and projects as assigned.

Ensure all work products comply fully with standards, policies, and mission of MCRA.

Required Qualifications: Bachelor’s degree in a scientific discipline (engineering, or a heavily technical writing-based curriculum preferred); Master of Science, Master of Science in Engineering, or PhD preferred.

Previous FDA experience required.

7+ years of regulatory affairs experience required.

4+ years of cardiovascular medical device experience required. The ideal candidate will have direct experience in one or more of the following device areas:

Cardiac Diagnostics Devices, Cardiac Electrophysiology Devices, Implantable Electrophysiology Devices, Cardiovascular Digital Health Technologies

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

Possesses engineering and/or biological background to assist with pre-clinical and clinical strategies and can effectively communicate these strategies to internal team members and clients.

Experience developing and/or reviewing regulatory submissions to the US FDA and/or experience with international regulatory affairs and the regulatory bodies governing them.

Knowledge and experience utilizing research and providing statistical analysis.

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

Must be able to manage multiple projects and deliverables simultaneously and generate meaningful results.

Ability to adapt to a rapidly changing environment and quickly identify new trends and changes specific to the industry.

Strong professionalism with customer relations and managing client relationships.

PC/Technical skills: strongly proficient in MS Office Suite, Excel, Word, PowerPoint.

Excellent oral and written communication skills and presentation skills.

Ability to lead a team and mentor junior Regulatory Team members.

Experience working with C-Level and senior management.

Special Requirements: Travel: 10% (to the Company’s offices and for meetings/conferences/etc.)

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.

MCRA, LLC is an equal opportunity/Affirmative Action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.

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