Required Skills / Qualifications:
- High School Diploma or GED
- Minimum of 8 years" experience in regulatory affairs (510(k), PMA, QSR)
Preferred Skills / Qualifications:
- Deep professional know-how and experience U.S. Regulatory Affairs.
- Transfers and applies 'know-how' to/in various contexts. Solid professional judgment and problem solving competence. Improves existing processes and approaches.
- Provide specialized guidance or train support and professional staff. Leadership qualities and role model qualities.
- Is expected to adopt existing concepts, methodologies, etc. in order to create and open up new ways of approaching and fulfilling specific internal and external client requests or project requirements.
- Demonstration of Key Responsibilities, Knowledge, Influence & Impact as presented above or equivalent education, technical knowledge with Medical Devices or Imaging Products may suffice.
- 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.