Quality Assurance and Regulatory Affairs Manager

Company: Jobot
Location: Olympia
Posted on: May 9, 2022

Job Description:

Quality Assurance & Regulatory Affairs Manager

This Jobot Job is hosted by Erica Hatch

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Salary $125,000 per year

A Bit About Us

We are on a mission to provide the highest quality, state of the art, precise, reliable and affordable solutions to our customers.

Why join us?

We believe in a culture of innovation, collaboration, and partnership to perfect our product and develop new applications to help our customers provide the best care for their patients

Job Details

Essential Duties And Responsibilities

Lead the organization in the development, documentation, and implementation of policies and procedures that define, implement, and support the Quality Management System.

Ensure that quality system requirements are effectively established and maintained in accordance with all applicable medical device regulations

Monitor the conformance of the ISO 13485 2016 Quality Management System and products to established requirements and provide periodic reports to management.

Lead in the root cause analysis of non-conformance, apply quality management principles and implement corrective actions.

Collaborate cross-functionally with engineering and production teams to ensure products are manufactured in accordance with specifications. As needed, participate in the engineering change order process, by reviewing engineering and manufacturing document release and changes, as requested. Enhance customer satisfaction through reporting of quality status and facilitation of continuous improvement of company products and services.

Plan, promote, and organize training activities related to product quality and reliability. Provide counsel, training, and interpretation of regulatory requirements to Company personnel.

Manage the coordination and preparation of regulatory submissions and product/marketing clearance/approval, ensuring they are prepared and submitted accurately, completely, and in a timely manner to meet and maintain business objectives.

Maintain FDA regulatory compliance including registrations, listings license amendments, 510(k) submissions, letters to file, labeling, UDI, and other requirements

Assist in ensuring compliance to Medical Device Regulations in Canada and Medical Device Directive/Regulation (MDD/MDR) in the EU.

Conduct and manage internal audits and provide guidance regarding best practices and continuous improvement.

Promote audit readiness, prepare quality and operations teams for audits by external bodies, and facilitate audits as needed

Oversee the execution of corrective action plans, tracking and verifying those deficiencies are corrected.

Maintain expert current knowledge of FDA, Health Canada, and other applicable foreign country regulations, legislation, best practices, and guidelines related to QA/RA, monitor changes to applicable laws and regulations, identify impact to the business, and in collaboration with other stakeholders, develop response strategies and/or a work plan and complete according to a deadline.

Oversee the maintenance of regulatory affairs files (e.g., establishment registrations and device listings, quality certificates, and device/facility licenses) and distribute information as required to support key stakeholders.

Assist in representing the Company before regulatory authorities.

Education and Experience

Bachelor's degree in engineering, a related technical field, or equivalent.

Minimum seven (7) years of progressive work experience in regulatory and quality systems in an FDA-regulated industry.

Three to five years of documented experience in preparing domestic FDA, EU, and Health Canada product submissions in a medical device Class II/ III environment.

Extensive knowledge of FDA, EU, and Canadian medical device regulations.

Experience With FDA/GMP Requirements For Medical Devices.

Experience in Managing corporate Quality Systems per ISO 13485 2016.

At least 3-4 years of people management experience with a track record of building and leading high-performance teams.

Ability to work in a project team environment.

Knowledge of the regulatory submission requirements for FDA Class II medical devices, and equivalent classification requirements for international submission.

Computer Proficiency with MS Office (Word/Excel/Access/Outlook).

Excellent verbal and written communication skills.

Excellent organizational, and interpersonal skills.

Excellent documentation skills including record maintenance/ tracking and understanding document traceability.

A detail-oriented individual with a "can-do" attitude and ability to work in a team environment as well as individually with minimal supervision.

Ability to work in a fast-paced environment with multiple tasks/projects.

Preferred Qualifications

Experience in Medical device, Medical Laser, or electronic device products.

Experience with UL/ETL/CSA certification process.

Experience interacting with regulatory bodies.

Supervisory Responsibility This position oversees the QA team and supervises the following positions Sr Quality Control Technician, Document Control Specialist, Receiving Inspector, and Quality/Complaint Specialist.

Position Type / Expected Hours of Work This is a full-time onsite position. Hours of work are Monday through Friday, up to 40 hours per week.

Travel up to 15% with occasional overnight and international may be required. Travel is primarily local during the business day, although some out-of-the-area and overnight travel may be expected.

Interested in hearing more? Easy Apply now by clicking the "Apply" button.

Keywords: Jobot, Olympia , Quality Assurance and Regulatory Affairs Manager, Executive , Olympia, Washington