Regulatory Affairs

Location: Netherlands

SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!

THE COMPANY

Our client is a professional Medical Devices organization, based in Noord-Brabant Netherlands.

Medical Devices company based in Eindhoven.

ROLE DESCRIPTION

The most important part of this position is the Regulatory Affairs support of submissions and on-going regulatory compliance for product development and life-cycle processes.

The broader the knowledge, the better it is.

Any QA knowledge would be a big plus.

RESPONSIBILITIES

REGULATORY AFFAIRS

- Monitor MDD, European and emerging markets regulatory environments and provide assessment on the new and changing regulations.
- Evaluate potential MDR complaints and review risk assessments to determine Medical Device Reporting eligibility. Complete MDR reports as required, and assure timely submission to health authorities.
- Assure and maintain regulatory device product and facility registrations, listings, license renewals and annual registrations.
- Support registration into emerging markets.
- Liaison with health authorities during inspections, prepare pre-inspection documentation, and support the inspection process.
- Manage communication and documentation on all recalls, product safety issues, field actions and failures to health authorities as required.


QUALITY ASSURANCE SYSTEM
- Works with Quality & Regulatory Manager EMEA to help develop, implement, and maintain the quality management system (CAPAs, Complaints, NCRs, Internal Audits, ECNs and NCs) for EMEA in compliance with applicable industry standards and regulations.
- Coordinate with other management personnel in formulating and establishing company policies, system level procedures, and associated documentation.
- Manage and perform internal audits and inspections.
- Assist with the implementation, management and administration of the departmental electronic document management system (Plaza).
- Develops, analyzes, and presents operations quality data (for executive management review) to demonstrate the effectiveness of the quality management system and to evaluate where continual improvement can be made.
- Liaison with ISO notified bodies during audits, prepare pre-inspection documentation, support annual certification renewal documentation and support the audit process.

LEGAL ADMINISTRATION
- File potential legal/injury/incident cases with insurance company.
- Supports case by preparing case evidence and documentation.
- Monitor case progress and inform legal counsel of changes.
- Point of contact for insurance company during initial investigation of case.
- Prepare reports as required.

EXECUTIVE ADMINISTRATION
- Plan and schedule meetings and events.
- Prepare reports and meeting minutes as required.
- Other duties as required.

REQUIREMENTS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

- Bachelor’s Degree or equivalent experience.
- 3-5 years of working knowledge in ISO13485 environment with experience of the MDD 93/42/EEC alongside emerging market regulations as applicable.
- Experience with Quality System Documentation and good documentation practices.
- Regulatory Affairs Certification and Certified Quality Auditor preferred but not essential
- Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
- Ability to write reports, business correspondence, and procedure manuals.
- Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
- Demonstrates continuous pursuit of regulatory knowledge to obtain experience and expertise in product submissions and regulatory topics, including European regulations and policies applying to medical devices, labeling and promotional materials, MDD 93/42/EEC, and global registration.
- Strong knowledge of ISO 13485.
- Person must have extensive computer knowledge in MS products.

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Tim Thuijs.