MCRA, an IQVIA business is seeking a strong Senior Associate to join our Regulatory Affairs team. This individual will play a key role in supporting regulatory and human factors engineering initiatives across a diverse portfolio of medical device and life sciences clients.

Responsibilities:

Draft usability engineering file, conduct use related risk analysis, conduct post-market surveillance data analysis, design usability studies and draft protocols, support usability study execution and report drafting.Develop and execute regulatory services for client companies, including however not limited to:Regulatory Submissions (e.g., 510(k), IDE, PMA, IND, BLA, & IND, Technical Documentation, STED, CERs)Regulatory Strategy, Analysis & DevelopmentDesign, Review & Implement Pre-Clinical TestingCommunicate with regulatory bodies and clients with support of senior MCRA staff.Work collaboratively with other MCRA departments, including clinical, RHEMA, and quality assurance.Complete other projects and responsibilities as assigned
Qualifications:Bachelor’s degree or higher in scientific, engineering, or regulatory discipline with experience with medical device development either through school projects or work experience is required; experience with medical device usability engineering is preferred. Candidates with animal testing, clinical testing, and bench testing experience are highly preferred. Surgical and clinical shadowing experience or cadaver lab experience beneficial.Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.Possesses strong written, including medical/technical writing, and verbal communication and presentation skills.Possesses an understanding of engineering and a biological background to assist with pre-clinical and clinical strategies and is able to effectively communicate these strategies to internal team members and clients.Strong research, analytical, critical-thinking and problem-solving skills.Able to lead projects with support from MCRA staff; takes initiative and ownership of results; demonstrates self-accountability.Excellent organizational and prioritization skills with the ability to handle multiple tasks and meet deadlines.PC/Technical skills - MS Office, Excel, Word, PowerPoint.Must be polished and professional.Effective interpersonal skills; shows confidence with subject matter Knowledge and experience utilizing research evidence and providing statistical analysis is advantageous.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe

The potential base pay range for this role, when annualized, is $53,600.00 - $133,900.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.