PlasmaJet · 10 hours ago
Associate Director, Regulatory Affairs & Quality Engineering
Roswell, GA
Full-time
Onsite
Lead/Staff, Director/Executive
$85K/yr - $85K/yr
5+ years expPlasma Surgical, Inc. is a designer, manufacturer, and distributor of surgical products used in over 20 countries. The Associate Director of Regulatory Affairs and Quality Engineering is responsible for managing quality systems and ensuring compliance with regulatory requirements, while also acting as the Management Representative.
ManufacturingMedical DeviceProduct Design
Responsibilities
Implementation, maintenance, and ensuring compliance with the Quality Management System (QMS) throughout Plasma Surgical to ensure compliance with all relevant national and international standards including in particular ISO 13485 and the FDA Quality System Requirements set out in 21 CFR Part 820, as revised
Customer Complaints, investigations, communications as appropriate, and reporting
NCR/CAPA, including root cause analysis, investigation, and implementation activities
Supplier Management
Training, conducting as appropriate, and related documentation
Post Marketing
Internal and External Auditing, including hosting, as appropriate
Calibration, including management of Quality personnel as applicable
Quality Control (QC), including management of Quality personnel as applicable
Management Review
Maintenance of all product technical files and corporate Quality System documents to ensure compliance with Federal US legislation and the Essential Requirements of the European Medical Devices Directive
Collaboration with other departments to ensure that changes to literature and/or other external communications are compliant and consistent with indications for use
Interact with all functional groups to drive the implementation of CAPA activities, to include effectivity measures such as root-cause analysis and change control
Oversee via Document Control Management, the maintenance of all records of quality and regulatory compliance including the TrackWise document management system
Ensures product safety, reliability and quality through the effective use of manufacturing quality planning, risk analysis, statistical methods and process controls. Develops and maintains statistically valid sampling plans for Quality Control inspection of incoming components, in-process sub-assemblies as well as functional testing and finished inspection of products
Works within the Quality group to reduce reject (NCR) levels by timely identification and evaluation of issues from Goods receiving; In-process and all functional testing / Finished Product Release Inspections
Coordinates with engineering and R&D regarding non-conformance investigations for components and in process materials/subassemblies. Acts as an integral partner with the manufacturing team to develop and execute strategies in support of manufacturing requirements and production output
Creates/updates product design and technical documentation to support MDR and FDA 510(k) submissions and approvals
Creates and supports software validation in compliance with IEC 62304
Registration of the Plasma Surgical group companies and products with regulatory bodies in each country in which the company operates and markets its products
Preparation, filing and maintenance of files to obtain regulatory approval for the company’s products in each country in which the company markets its products; including FDA approvals in the USA
Advise senior management on all quality and regulatory requirements pertaining to the companies’ products
Advise research and development staff and sub-contractors on appropriate steps to be taken in the design of products to achieve compliance with national and international standards for product safety and regulatory compliance, and plans and coordinates validation and verification studies
Advise marketing and clinical support staff on the regulatory requirements that apply to the clinical trials of the companies’ product
Work closely with research and development to ensure that all products and applications are developed in compliance with design controls
Has authority over and accountability for:
Ensuring that quality management system requirements are effectively established and maintained in accordance with Plasma Surgical policies and regulatory requirements
Audit preparedness, presentation, hosting, and follow up activities in a timely manner
Regular reporting on the performance of the quality system to senior management with responsibility for management review
Qualification
Required
Bachelor's or Associate degree, preferably in Life Sciences, Industrial, Mechanical, Manufacturing, or Engineering and/or equivalent direct work experience in related Quality and Medical Device Industry
5+ years experience with quality and regulatory affairs gained within a medical device company, including familiarity and practice of both US Federal regulations and European directives governing medical devices
Communications skills and appropriate patience to be able to train and encourage staff to play their part in all quality and regulatory matters; including those for whom English is not their first language
Experience and skills in auditing quality systems
Ability to draft operating procedures and write regulatory submissions with clarity, accuracy and attention to detail
Ability to communicate effectively and appropriately with regulatory and quality officials and auditors
Ability to travel up to 20% for both domestic and international responsibilities in each of the countries in which the company operates
A willingness to work with small teams in a growing organization and play a full part in the development of the company
FDA 510(k) submissions and approvals: 5 years (Required)
quality and regulatory in the medical device industry: 5 years (Required)
auditing quality systems: 5 years (Required)
Location: Roswell, GA 30076 (Required)
Work Location: In person
Benefits
401(k)
401(k) matching
Dental insurance
Health insurance
Life insurance
Paid time off
Vision insurance
Company
PlasmaJet
We are experts in plasma energy with pioneering research in medical plasma technology and a robust patent portfolio.
51-200 employees
H1B Sponsorship
PlasmaJet has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (1)
Funding
Current Stage
Growth StageLeadership Team
B
Brian Tippett
President, CEO, and Chief Medical Officer
Company data provided by crunchbase