Required Skills / Qualifications:
- Bachelor"s degree
- Minimum of 7 years" experience in clinical and regulatory affairs
- Minimum of 5 years" experience in research methodology (clinical investigation design, biostatistics), scientific literature review (PUBMED, EMBASE, MEDLINE etc.) and medical writing.
- Minimum of 5 years" experience in FDA (21 CFR 212, 21 CFR 820 etc.) , EU (MDR, MDD, MEDDEV 2.7/1), ISO 14155/GCP and other regulatory standards.
Preferred Skills / Qualifications:
- Master"s Degree in clinical and regulatory affairs
- Experience in claims management and mapping clinical evidence to clinical claims.
- Experience In EU clinical trials and experience with Institutional Review Boards (IRB) and Ethics Committee (EC).
- Experience with regulatory submissions for EU Class III devices .
- Demonstrated project management and planning experience.
- Demonstrated problem solving capability and results orientation.
- Strong critical/analytical thinking and problem solving skills.
- Strategic planner, self-starter, collaborative team player and clear thinker.
- Excellent interpersonal, written / verbal communication and presentation skills.
- Ultrasound and imaging catheter experience preferred.
- Advanced degree (MD, PharmD, PhD etc.) and experience in radiology, cardiology and medical imaging.
- In-depth understanding of EU MDR and Risk Managemen.
- Regulatory Affairs experience for EU CE Marking and supporting technical documentation.
- Key Working Relationships
- Works with a cross functional team.
- Upon offer of employment, the individual will be subject to a background check and a drug screen.
Aleron companies (Acara Solutions, Aleron Shared Resources, Broadleaf Results, Lume Strategies, TalentRise, Viaduct, and Aleron's strategic partner, SDI) are Equal Employment Opportunity and Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender identity, sexual orientation, national origin, genetic information, sex, age, disability, veteran status, or any other legally protected basis. The Aleron companies welcome and encourage applications from diverse candidates, including people with disabilities. Accommodations are available upon request for applicants taking part in all aspects of the selection process.
Applicants for this position must be legally authorized to work in the United States. This position does not meet the employment requirements for individuals with F-1 OPT STEM work authorization status.