Career Opportunities
Resumes submitted online receive priority screening over other methods of submission.
Positions Currently Available:
- Director of Regulatory Affairs and Quality Assurance
REPORTS TO: Chief Strategic Officer
LOCATION: Honolulu, HI
DUTIES AND RESPONSIBILITIES:
The Director of Quality Assurance and Regulatory Affairs has primary responsibility for assuring that the company has effective systems which result in compliance with medical device regulations and standards, and for the completeness and quality of regulatory submissions. The duties of this position include:
- Function as Management Representative responsible for implementing and maintaining a compliant Quality System per regulatory requirements; represent Hoana during medical device regulatory agency audits and inspections.
- Promote organization’s adherence to industry standards in regard to management responsibility, product and process control at contract manufacturers, product quality assurance, design controls including verification and validation, corrective and preventive action program, document and data controls, supplier management including supplier audits, statistical techniques, etc. This includes technical review and approval of individual scientific and engineering protocols and reports as well as the identification and implementation of continuous improvements for the Quality System.
- Serve as regulatory representative to product development teams and proactively interact with internal functional areas, corporate partners, and oversight of contract manufacturers.
- Maintain excellent working relationships with the FDA, other regulatory agencies, internal project team members, collaborators/partners and contract manufacturers.
- Oversee internal quality system audits, supplier quality audits, and due diligence audits.
Provide support with compliance and quality assurance decisions as needed to: Operations, R&D, Sales and Marketing, Technical Service, Clinical Affairs and Executive Management.
QUALIFICATIONS/REQUIREMENTS:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- BA/BS or higher in a scientific discipline.
- 8 to 10 years experience in quality systems and regulatory affairs, including management responsibility in a medical device company.
- Must have advanced knowledge of:
- US FDA Medical Device Regulations (e.g., 21 CFR 803, 807, 820)
- ISO 13485 o ISO 14971
- Medical Device Directive (MDD)
- Japanese Medical Device Regulations (J-GMP)
- Canadian Medical Device Regulations (CMDR)
- ASQ or RAPS certification preferred.
- Quality Engineering background a plus.
- Ability to communicate effectively, both orally and in writing.
PHYSICAL DEMANDS:
The physical demands described here are representative of those that must be met by the employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Ability to work in a clinical environment which requires following basic safety precautions. Requires a moderate amount of fairly steady physical activity including a moderate amount of walking and standing. Ability to lift/lower, push/pull up to 25 pounds. Created 8-22-06 Please email resumes in Word format to info@hoana.com.
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Edited September 2009
Please email resumes in Word format to info@hoana.com.
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