HBO/WO Internship - EU MDR Quality & Regulatory Compliance Assistant
- Datum plaatsing: 30 juni 2022
- Solliciteer voor: 30 maart 2023
- 1832x Bekeken
Pride Mobility Products Europe BV (hereafter: Pride BV) is seeking a paid trainee for the Quality & Regulatory department. The primary task of this position will be assisting the Person Responsible for Regulatory Compliance (hereafter: PRRC) in carrying out and/or documenting checks and audits within the subsidiaries within Pride Europe. This includes managing incoming and outgoing documents, coordinating complaint management together with the PRRC, and stay informed and gathering and analysing information on new relevant legislation.
We are the EU Authorised Representative of the USA based Pride Mobility Products Corporation, a successful international wholesaler of powered wheelchairs, mobility scooters and lift chairs.
Our multicultural team is known for our focus on customer experience and product quality. We are looking for an intern who is eager to learn and grow to support the PRRC. Our office is located in Enkhuizen.
Tasks and responsibilities:
- Keep quality management system (QMS) records and other documentation up-to-date
- Monitor and collect information on relevant policies, legislation and developments relating to EU MDR 2017/745, EU GDPR 216/679, etc.
- Make sure documents are processed correctly in accordance with the established regulations
- Advise and support PRRC, and the management in the implementation and assurance of the company’s quality policy
- Coordinate complaint management, and advise on corrective actions to prevent recurrence
- Provide both analytical support and legislative insight into strategic consulting engagements on an ad hoc basis
- Assist PRRC in carrying out internal audits and checks
- Inform, support and encourage employees to uphold the appropriate levels of quality and safety
Who are you?
- You are pursuing an HBO (final year)/WO degree in law, medicine, pharmacy, engineering or another scientific program
- The trainee will gather regulatory information, critically review it and distil key takeaways and implications for the stakeholder of Pride BV
- Strong teamwork skills as well as the ability to work independently are critical to this role
- BA/BS is required. An MA/MS (completed or in progress), specifically with work in EU MDR 2017/745 or medical device/quality assurance (ISO 9001/ISO 13485), is a plus
- Strong quantitative skills with a comfort level using MS Excel is critical
- Strong written and verbal communication skills in both English and Dutch
- Knowledge of German, French or Spanish is a preferred
- Strong problem-solving/critical thinking skills
- Understanding of the medical device industry, including basic familiarity with EU MDR 2017/745 regulatory environment is strongly preferred
- Familiarity with and interest in LEAN principles, ISO 9001 and ISO 13485 is a plus
- Experience working in a fast-paced environment with rapidly shifting priorities such as consulting is desirable
Who are we?
We are Pride Mobility Products Europe B.V., market leader in the design, production and distribution of personal mobility products, such as electric wheelchairs and mobility scooters. From our 6000 m2 distribution center in Enkhuizen we ship our products and parts to the whole world. With our products, we are committed to supporting people with mobility impairments to lead an as active a life as possible!
What do we offer?
- Traineeship duration would be minimum 20 weeks, based mainly in Enkhuizen
- Prospect of employment
- A monthly salary of around €450 will be received by the trainee
- Work on location
- Supervision by an (internship) supervisor
Please submit your CV and cover letter to email@example.com. Interviews will be conducted online on a rolling basis.
Deze vacature sluit aan op:
- HBO - Rechten
- International Business
- Juridisch medewerker