Associate, Digital Health Regulatory Affairs
The Associate, Digital Health Regulatory Affairs will be a critical team member supporting US and international regulatory strategy and submissions for the firm’s digital health clientele. The primary roles and responsibilities include participating in the writing and reviewing of regulatory submissions with support of senior MCRA staff.
- 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
- Communicate with regulatory bodies and clients with support of senior MCRA staff.
- 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 electrical engineering, software engineering, or similar required. Advanced degree preferred.
- Minimum of 1+ years of direct experience in regulatory affairs related to medical devices, drugs and/or biologics, which includes experience assisting in the writing and/or reviewing of regulatory submissions.
- Digital health device experience (or a strong passion for digital health) is a huge plus
- An understanding of engineering and a biological sciences to assist with pre-clinical and clinical strategies with the ability to effectively communicate these strategies to internal team members and clients.
- An understanding of clinical research and data analysis is required.
- International regulatory experience including developing Technical Files, Design Dossiers, and Clinical Evaluation Reports (CERs) is preferred.
- 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 preferred.
- Excellent organizational and prioritization skills with the ability to handle multiple tasks and meet deadlines while working independently.
- 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.
- Potential for travel Up to 10%.
Compensation & Benefits
- Salary + bonus
- Medical, dental and vision insurance
- Company-paid life insurance
- Company-paid STD and LTD
- Generous PTO policy
- Fully paid maternity leave benefits
- Pre-tax public transit and parking benefit
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.
Learn more here
Job posted: 2021-05-19