EDUCATION, EXPERIENCE, QUALIFICATIONS AND SKILLS:
- Bachelor’s Degree in a technical discipline such as such as Engineering, Chemistry, Biology, Computer Science or 3 years of experience and working toward a Bachelor’s degree in one of the aforementioned fields of study
- Minimum one (1) year work experience in a regulated industry such as Medical device, biological, or pharmaceutical
- Strong verbal, written and interpersonal communication skills
- Team player with ability to facilitate meetings with cross functional teams
- Effective research and analytical skills
- Ability to read, analyze and interpret legal documents, technical documents, professional journals and regulatory standards
- Strong planning and organizational skills
- Computer Skills – Excellent computer skills including but not limited to Microsoft Office
QUALITY AND REGULATORY REQUIREMENTS:
- Quality System knowledge including the quality manual, quality policy, and applicable procedures and work instructions
- Establish, implement, and maintain the quality system in accordance to FDA Quality System Regulations, ISO 13485, European Union Medical Device Directives/Regulation, Japanese Ministry of Health and Welfare, Canadian Medical Device Regulations, Australia TGA Medical Device Regulation, and Brazil ANVISA Medical Device Regulations.
- Responsible for reviewing and signing all regulatory affairs company document on Aspen Surgical’s behalf relating to Domestic and International requirements
Note::The inability to perform any of the following physical requirements does not preclude an applicant from consideration unless, following an individualized analysis, it is determined that the physical requirement is an essential job function and the applicant is unable to perform such function with or without reasonable accommodation
Please refer to the Essential Duties and Responsibilities.
At Aspen Surgical, we strive to build a diverse work force through equal opportunity employment that embraces and leverages the differences that each individual has to offer. This job description is only a summary of the typical functions of the job and not intended to be an exhaustive list of all job responsibilities, tasks, and duties.Aspen Surgical Products, Inc. is an equal opportunity Employer F/M/Disability/Vet/Sexual Orientation/Gender Identity.