Manager, Regulatory Affairs
Founded in 2004, 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 the Greater Zürich area, Switzerland and serves more than 800 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 Manager, Regulatory Affairs will be a critical team member supporting regulatory strategy and submissions for the firm’s clientele. The primary roles and responsibilities include technical writing of regulatory submissions, managing the development of regulatory submissions, development of overall regulatory strategy, and communicating with internal and external teams. The Manager, Regulatory Affairs may also manage various personnel during various projects, as well as act as a mentor and trainer for junior employees.
Develop and execute regulatory services for client companies, including however not limited to:
Regulatory Submissions (510(k), IDE, PMA, IND, BLA, & IND)
International Regulatory Submissions (Technical Files, Design Dossiers, Clinical Evaluation Reports (CERs))
Regulatory Strategy, Analysis & Development
Design, Review & Implement Pre-Clinical Testing
Provide consultation on biological safety risk assessment, testing plans/strategies, test parameters and methods through understanding and implementation of analytical/chemical, in silico, in vitro, and in vivo testing methodologies in accordance with ISO Standards, FDA Guidance, and global regulatory requirements
Manage, mentor, and train junior members of MCRA’s regulatory department.
Communicate with regulatory bodies and clients with minimal support of senior MCRA staff.
Provide project leadership while maintaining relationship with client companies.
Work collaboratively with other MCRA departments, including clinical, reimbursement, and quality assurance.
Complete other projects and responsibilities as assigned.
B.S. or B.A. in a scientific, engineering, or related discipline required. Advanced degree preferred.
5+ years of experience in regulatory affairs related to medical devices, with direct experience writing and/or reviewing of regulatory submissions.
Experience developing and/or reviewing regulatory submissions to the US FDA and/or experience with international regulatory affairs and the regulatory bodies governing them.
An understanding of engineering and biological sciences to assist with pre-clinical and clinical strategies with the ability to effectively communicate these strategies to internal team members and clients.
Possesses domain specific regulatory expertise.
An understanding of clinical research and data analysis
Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
Strong research, analytical and problem-solving skills.
Knowledge of medical, anatomical, and physiological terminology
Excellent organizational and prioritization skills with the ability to handle multiple tasks and meet deadlines while working independently.
Strong written and verbal communication and presentation skills.
Strong intellectual curiosity and a desire to develop an in-depth understanding of systems, business processes and complex issues.
Proficiency with MS Office Suite (Outlook, Word, Ppt, Excel) and internet applications.
Excellent oral and written communication skills.
Ability to read, analyze, and interpret complex documents.
Travel Up to 10%.
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.
COVID-19 Recruitment Information: MCRA, LLC is monitoring COVID-19 activity. The health and wellbeing of our staff is of the utmost importance to us, and we continue to hire for all open roles with interviewing and on-boarding done virtually. Our new hires and current staff working from our Manchester, CT, New York, NY and Washington, DC offices will temporarily work from home until it is safe to return to our offices.
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Job posted: 2021-05-19