The QA /RA Director serves as the lead Quality Management and Regulatory Affairs representative for Noble International and leads, manages and supports all medical device Quality System and Regulatory activities.
ESSENTIAL JOB FUNCTIONS:
Serves as the official correspondent to FDA, responsible for the annual registrations and device listings.
Ensuring compliance with FDA and other applicable international regulations and requirements for the design and development of medical devices and provide general regulatory support to the organization.
Responsible for leading all RA related activities
Facilitate external Quality System audits (ISO registration, Client Supplier Quality, etc.) and guide the organization during FDA Inspections (QSIT format).
The position will be responsible for ensuring regulatory compliance of Noble’s product realization process for the company’s growing line of drug delivery ancillary products; this position will also support ongoing product conformity requirements.
This position ensures that national and international medical device and ISO compliance regulations are met for the design and development of medical devices, including FDA’s Quality System Regulation (21 CFR Part 820) and related FDA regulations, ISO 13485, European Medical Device Directive, and others.
This position ensures that ISO:9001 compliance is met for the design and development of non-regulated devices. Administer and manage all aspects of an effective Noble Quality Management System (QMS)
Lead the development and implementation of quality procedures, work instructions, and forms to coincide with operational and process related changes to daily work flow.
Conduct Management Reviews to monitor the suitability and effectiveness of QMS implementation and applicable regulatory requirements.
Provides support to the company in the design, development, manufacture, and improvement of regulated medical devices and non-regulated devices.
Responsible for regulatory compliance of risk management, validation and conformity evaluation activities within the organization.
Ensuring that there are no repeat non-conformances from company audits.
Leads in the understanding and awareness of US, EU and other international regulatory requirements to ensure compliance. Disseminates and provides guidance and continuing education as applicable.
Prepares and provides guidance regarding required documentation (510(k)s, technical documentation files, dossiers) for domestic and foreign submissions and registrations.
Lead efforts to ensure timely evaluation of nonconforming product at Noble’s manufacturing sites.
Lead the review and approval of site corrective action plans for product and process QMS audits.
This position has direct supervisory responsibilities over a small QA/RA team.
Provide support to sales efforts by responding to client questionnaires and requests for proposals (RFP’s) and by presenting Quality System information (regulated and non-regulated) to clients in onsite meetings.
Bachelor’s degree in engineering, science, medical, or regulatory discipline is required.
Minimum of 10 years of experience in the medical devices industry or related regulated products is required; experience regarding medical device design, development, and manufacturing regulations, especially 21 CFR Part 820 Quality System Regulation, CE, as well as ISO 13485 requirements is essential.
FDA compliant medical device Quality System and Regulatory Affairs experience is required.
Experience with regulatory requirements outside of the US is an asset.
Substantial experience with design control and development as well as verification and validation of medical devices.
Premarket Experience:Experience supporting medical device regulatory submissions (e.g., 510(k)s and/or PMAs) is an essential element of this position; application of quality and regulatory requirements in the design and development of medical devices.
Experience with electro-mechanical device submissions (including experience with IEC 60601 and other applicable technical standards for establishing the safety and effectiveness of medical electrical equipment); software submissions (including verification and validation requirements of software as a medical device, software life cycle and experience applying ISO 62304 principles), as well as risk analyses (especially applying ISO 14971 principles) is highly preferred.
Postmarket Experience:Experience with recalls, corrections, removals, and MDRs is preferred. Knowledge of the international registrations process would be a plus.
Ability to work independently and identify and/or resolve quality issues/discrepancies with others in a proactive, diplomatic, flexible, and constructive manner.
First-hand experience with FDA Inspections for medical device manufacturers using the QSIT inspection procedure.
First-hand experience composing documented responses to FDA 483 Observations.
Must have the ability to make effective presentations to the organization and clients.
Proven ability to prioritize and manage multiple projects and meet deadlines as required.
Strong appreciation of the impact of regulatory bodies on medical device product life-cycle is required.
Strong organizational and written/verbal communication skills.
Proficient with PC
Approximate 10% of time traveling
Master’s degree in engineering, science, medical, or regulatory discipline
Background in product development
Prior QMS auditing experience in a regulated environment; ASQ Certifications, CQA or Certified Lead auditor is desired
Regulatory Affairs Certification (RAC)
High profile project management experience
PHYSICAL DEMANDS AND WORK ENVIRONMENT:
Mental- Requires a relatively high degree of concentration intermittently to compile reports and analyze data approximately 50% of time; periods of mental effort and concentration followed by other aspects of the job with lesser concentration and attention requirements.
Physical- Requires walking/standing approximately 20%, sitting approximately 80% and lifting up to 50 lbs. approximately 1% of time; involves repetitive stooping, forward bending and crouching approximately 10% of time.
Manual Dexterity- Requires use of hands, arms and feet for repetitive lifting; use of hands and arms to operate computers, copy machine and other general office equipment and to record written information.
Audible Demands- Requires ability to hear verbal instructions and to communicate with internal departments and outside sources in person and via telephone.
Visual Demands -Requires ability to read written instructions, correspondence and other documentation as well as operate office equipment such as computers and printers. Color and depth perception not necessary.
Environmental- Requires capability of performing essential job functions in an established office environment under lighting and climate control tolerances. Noise level is moderate.
Additional Salary Information: Salary is dependent on experience
About Noble International, Inc.
Noble develops injection and inhaler training products for pharmaceutical companies to distribute as part of patient and healthcare provider training and education materials. These trainers mimic the real devices look and function to help patients learn how to correctly use the real device. Proper usage of a syringe or inhaler ensures patients receive the full dose of the medication, which in turn helps with their condition.