Senior Associate, Regulatory Affairs- Human Factors
United States
Regulatory Affairs – Digital Health /
Full-time /
Remote
MCRA, an IQVIA business, 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 a global presence in Japan and Europe and serves more than 1500 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.
MCRA 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.
Responsibilites:
- 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 & 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, RHEMA, and quality assurance.
- Complete other projects and responsibilities as assigned
Qualifications:
- Bachelor’s degree or higher in scientific, engineering, or regulatory discipline
- 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.
- Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
- 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.
- Effective interpersonal skills; shows confidence with subject matter
- Knowledge and experience utilizing research evidence and providing statistical analysis is advantageous.
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, an IQVIA business, 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.
