Associate, Regulatory Affairs
The Associate, Regulatory Affairs will be a critical team member supporting US and international regulatory strategy and submissions for the firm’s clientele. The primary roles and responsibilities include writing and reviewing regulatory submissions, development of overall regulatory strategy and communicating with regulatory bodies and clients 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 a scientific or related discipline required. Advanced degree preferred
1-3+ years of experience in regulatory affairs related to medical devices, drugs and/or biologics, assisting in the writing and/or reviewing of regulatory submissions.
Post-graduate education with strong research and technical writing curriculum may be substituted for experience.
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 written, including medical writing, 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%.
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
We are proud to be an Equal Opportunity Employer. MCRA maintains a drug-free workplace.
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.
Learn more here
Job posted: 2020-08-27