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Quality Assurance & Regulatory Affairs Engineer
Posted 2 days 21 hours ago by IMDS
About the Job:
We offer a challenging position for an QA/RA Engineer professional in an innovation driven Medical Device Company. With the emphasis on RA and Coordinating RA Marketing / Sales support, you work within a QA/RA team and daily act in a multi-disciplinary environment which includes contacts with external parties.
You get the ownership for driving regulatory compliance of the development and certification of our products, and furthermore the compliance of our Quality Management System (QMS), operations and the quality of our products. You are highly skilled in communication, have understanding of marketing and sales structure and you have a can-do attitude. You realize that quality is of paramount importance and you are passionate about solving problems through delivering solutions that truly stand out.
About the Tasks & Responsibilities:
The QA/RA Engineer participates within a New Product Development environment as well as an Operations and Sales environment. Typical tasks for the QA/RA Engineer are:
Regulatory Monitoring regarding the applicable regulators globally
Maintenance of Quality Management Procedures, - Guidance's and - Templates
Preparation and execution of regulatory product submission strategies including the assessment of submission files
Maintenance of Market Authorization Summary within the QMS
Coordinating the maintenance of Distributor Website Portal and Product Survey Results
Preparation of Country specific Sales RA support packets (Post Market Authorization)
Distributor and Regulatory Agent Contract Assessments
Review of New Product Development documentation
Review of Engineering -, Qualification- and Validation protocols and reports
Train new employees on Quality Management System
Execute internal audits (ISO 13485, cGMP) and DHF audits
About the Job Requirements:
BSc or MSc degree in exact sciences (e.g., Business Engineering)
Strong feeling for an engineering and commercial environment
Minimal 2 years of medical device work experience in RA and some experience in QA
Highly committed, respectful, trustful, eager and demonstrates ownership
Naturally accurate, convincing and pragmatic
Creates alignment between cross functional team members through effective communication and seeks cross-function cooperation
Has sufficient technical knowledge to enable high level communication with development, manufacturing engineers and field marketing / sales reps
Able to write clear reports in English, delivers presentations effectively to small and larger groups,
Can define objectives and break down into executable tasks with scheduling and tracking for overall plan execution; can prioritize activities by importance and meet tight deadlines.
About the Company:
IMDS (Interventional Medical Device Solutions), Roden, The Netherlands, is an innovative and international high-tech organization and is dedicated to improve the patient outcome of percutaneous coronary interventions (PCI). With strong focus on game changing in-house technology, we develop unique product solutions enable advance treatment options. IMDS is equipped as a Centre of Excellence in order to develop, improve and manufacture innovative solutions for Medical Devices. When you join IMDS, you are part of a highly motivated team that is helping to improve quality of life. IMDS offers the excitement and growth potential of an agile company with the strength and stability of an established industry leader. The environment is fluid and fast-paced, and the people work together to make a difference every day. The atmosphere is friendly and team-oriented. Working at IMDS gives you the opportunity to make a positive impact on the lives of others. IMDS is committed to building and maintaining a workforce that reflects the diversity of its global customer base.
About what we offer:
Engaged international working environment in a modern working location
Challenging job position with corresponding responsibilities
Personal development to become a professional QA/RA Engineer in a leading Medical Device Company
A competitive remuneration package
Position in the organization:
- Reporting to the Director QA/RA
