MCRA is the leading global full-service medical device, diagnostics, and biologics CRO and consulting advisory firm. MCRA delivers to its client’s industry experience, integrating its six business value creators: regulatory, clinical research, reimbursement, healthcare compliance, quality assurance, and distribution logistics to provide a dynamic, market-leading effort from innovation conception to commercialization. MCRA’s integrated application of these key value-creating initiatives provides unparalleled value for its clients. MCRA has offices in Washington, DC, Hartford, CT, New York, NY, and Tokyo, Japan and serves nearly 1,000 clients globally. Its core focus areas of therapeutic experience include orthopedics, spine, biologics, cardiovascular, diagnostic imaging, wound care, artificial intelligence, dental, anesthesia, general surgery, digital health, neurology, robotics, oncology, general and plastic surgery, urology, and in vitro diagnostic (IVD) devices and medical device cybersecurity. MCRA places particular emphasis on its expertise working with companies in all stages of development and throughout the technology life cycle by ushering technologies from the conceptual pre-clinical stage to market approval.

MCRA

Compliance

MCRA seeks Director, Cardiovascular Regulatory Affairs for cardiac device regulatory strategy.

•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.

Director, Cardiovascular Regulatory Affairs (Interventional Devices)

Support CRO leadership in clinical trials for neurology medical devices.

• Collaborate with other senior Clinical Affairs leadership and executive management to develop operating objectives, organizational structure, and staffing requirements.
• Ensure clinical trial projects are properly resourced, managed and executed within budget and in accordance with established timelines and quality standards.
• Implement techniques to improve productivity and maintain the most up-to-date practices.
• Direct the development of department orientation and other training programs as required.
• Direct the development and communication of departmental systems, SOPs, policies, and procedures.
• Collaborate with Clinical Quality Assurance on process for CRO vendor selection, evaluation, and oversight.
• Develop and review project documents for accuracy, completeness, and compliance with company or client SOPs, GCP, and other regulatory requirements.
• Lead and direct project team to ensure that project deliverables meet client timelines.
• Approve reports and study communications generated by the project team for distribution to sponsors and investigators.
• Ensure consistency and compliance with department and company SOPs as well as departmental training manuals.
• Develop and maintain positive relationships, both internal and external to projects, including clients, team members, and site personnel (PIs, Study coordinators, etc.)
• Submit status updates to the client/sponsor as required and respond to questions and concerns.
• Ensure that departmental training needs are identified and implemented.
• Collaborate with other MCRA business units on business development initiatives, including proposal development and bid defenses.
• Serve as a clinical project manager for client projects, as needed.
• Assist with professional development for Clinical Trial Managers, Clinical Research Associates and Clinical Trial Associates.
• Represent MCRA at conferences and meetings as needed.
• Complete other duties and projects as assigned.
• Ensure all work products comply fully with SOPs, regulations, standards, policies, and the mission of MCRA.

Director, Neurology Clinical Affairs

Accounting Manager

Manage transactions and provide accounting support for a medical device advisory firm.

• Assist Accounting department in monthly and year-end closing.
• Respond to year-end audit requests.
• Track and maintain invoices (Accounts Payable) and ensure payment is timely and accurate.
• Maintain Accounts Receivable and incoming bills / documents.
• Prepare monthly analysis or aging reports of both Accounts Payable and Accounts Receivable.
• Manage expense reports.
• Assist with compensation analysis and pay-roll related tasks.

Accounting Associate

Software Engineer

• Process Electronic Data Capture (EDC) data into analytical datasets
• Create Tables, Listings, and Figures to support Regulatory Clinical Trials
• Develop and maintain SAS programs for data importing, quality assurance, and reporting
• Produce Define XML/PDFs, aCRFs, and Reviewers Guides to support SDTMs and ADaMs
• Create listing and safety outputs (analysis datasets, tables, figures) to a high standard of quality and accuracy
• Create, document and validate macros at the table, listing and figure level
• Maintain PDVD according to the procedures for Planning, Executing, Tracking and Documentation of Programming and Validation activities
• Trouble-shoot and resolve programming issues in a timely and efficient manner
• Perform various tasks per project specific timelines under supervision
• Interface with client/sponsor organizations in team meetings
• Collaborate with other departments within MCRA
• 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 with SOPs, regulations, standards, policies, and the mission of MCRA

Statistical Programmer

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

Director, Regulatory Affairs - In Vitro Diagnostics

• 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.

MCRA Jobs in New York City

MCRA

Director, Cardiovascular Regulatory Affairs (Interventional Devices)

MCRA

Director, Neurology Clinical Affairs

MCRA

Accounting Associate

MCRA

Statistical Programmer

MCRA

Director, Regulatory Affairs - In Vitro Diagnostics

MCRA

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

MCRA