Sr Software Reg/Qual Systems Analyst
4 weeks ago
RQMIS is looking for a Senior Software Regulatory/Quality Systems Analyst – Medical Device and Combination Products person to join our team.
OVERALL RESPONSIBILITIES:
The Senior Software Regulatory/Quality Systems Analyst – Medical Device and Combination Products will provide overall support and management of client needs in the area of software quality system design and management. This support shall assure that the client will achieve compliance with specified objective(s) in terms of regulations and standards conformance, as well as, operational process effectiveness and efficiency. In addition, senior analyst shall assure the appropriate documentation and testing is identified for regulatory submissions. Provide support for the development, management and execution of client and/or public training courses in the area of software quality system design/ management/compliance. Provide leadership to RQMIS employees in the area of project management and quality systems. Support the development/ implementation/management of tools for RQMIS employees in performing their duties.
POSITION DUTIES & RESPONSIBILITIES:
- Assist and support client’s product development activities through interpretation and implementation of FDA’s GMPs, QSR, GTPs, ISO 9001, ISO 13485, 21 CFR part 820 requirements and other regulatory/standard requirements as they apply to the development and manufacturing of software-based medical products.
- Assure software documentation and testing satisfies IEC 62304 and IEC 82304 and will support US and EU/UK regulatory submissions.
- Assist in developing and maintaining client’s quality system procedures, inspection instructions, and related documentation in support of product development, production and post market activities.
- Apply Design of Experiments (DOE) to process qualification/validation.
- Design and implement IQ/OQ/PQ for client equipment and processes.
- Audit client’s quality system to assure compliance to the FDA’s QSR, ISO 13485, 21 CFR part 820 and other regulatory/standards requirements.
- Develop and implement tools for RQMIS employees in conducting their activities
- Develop and execute training programs used to educate clients or potential clients on how to implement regulatory and standard requirements such as FDA’s QSR, GTPs, ISO 13485, ISO14971, 21 CFR part 820, etc.
- Assist in the development of CMC regulatory submissions for domestic and international markets
EDUCATION & PROFESSIONAL EXPERIENCE:
- Working knowledge of Medical Device and Combination Products
- Bachelor’s degree in computer science/engineering/scientific field (biochemical engineer, biomedical engineer, pharmacist, chemist, biologist, microbiologist), or similar work experience
- 6 to 10 years’ experience with drug, biologics, tissue regulations/standards (including premarket submissions for domestic and international markets)
- Knowledge of domestic/international drug, biologics, tissue and combination product regulations/standards/guidance’s
- Strong attention to detail
- Strong computer skills, including word processing, spreadsheet and data programs
- Good oral and written communication skills
- Good leadership skills
- Ability to effectively manage multiple tasks while continuously assessing company and/or departmental priorities
PHYSICAL REQUIREMENTS:
The physical demands described here are representative of those that must be met by a teammate to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- While performing the duties of this job, the employee is regularly required to, stand, sit; talk, hear, and use hands and fingers to operate a computer and telephone keyboard reach, stoop kneel to install computer equipment, and interact/observe operations on a manufacturing floor.
- Specific vision abilities required by this job include close vision requirements due to computer work and observing manufacturing processes.
- Light to moderate lifting is required
- Ability to uphold the stress of traveling
- Regular, predictable attendance is required; including quarter-driven hours as business demands dictate.
The work environment characteristics described here are representative of those a teammate encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Moderate noise (i.e. manufacturing environment, business office with computers, phone, and printers, light traffic).
- Ability to work in a confined area.
- Ability to sit at a computer terminal for an extended period of time.
TRAVEL:
No more than 40%
If interested, please send your resume to employment@rqmis.com
Company DescriptionRQMIS Inc is located north of Boston Massachusetts area is a fast growing medical device/ biotechnology consultancy with focused in three principle areas, regulatory strategy/submissions, clinical study design/management and quality systems design/compliance. RQMIS Inc has been providing companies with strategic guidance on how to effectively navigate the FDA, UK and EU regulations for over 25 years in around the world.Company DescriptionRQMIS Inc is located north of Boston Massachusetts area is a fast growing medical device/ biotechnology consultancy with focused in three principle areas, regulatory strategy/submissions, clinical study design/management and quality systems design/compliance. RQMIS Inc has been providing companies with strategic guidance on how to effectively navigate the FDA, UK and EU regulations for over 25 years in around the world.-
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