Oorspronkelijke vacature omschrijving:

Your role as Regulatory Affairs Specialist

As a Regulatory Affairs Specialist you play a key role in processes that ensure patients' safety and regulatory compliance of all Neurosign's and Technomed's medical devices. You are also responsible for the maintenance and renewal of existing registration and licenses, worldwide. In this role, you will provide regulatory support for existing products for the maintenance of existing registrations and for territory expansion. You will interact with numerous internal and external customers worldwide including local representatives. This position is based in Maastricht, the Netherlands.

Your responsibilities are:

• Monitor, interpret, and implement national & international laws, regulations and guidance documents to Technomed products, processes, procedures and records. In collaboration with the Regulatory Affairs Team, recommend for the need to update, change, and/or introduce new requirements.
• Work within internal teams to implement the applicable regulatory requirements and ensure products, processes, procedures and records remain regulatory compliant and are maintained up to date.
• Act as Regulatory Affairs lead in defined project teams, playing a key role in regulatory impact assessment, identification and implementation of the regulatory strategy.
• Update and/or maintain technical documentation and registration files for regulatory compliance following change control.
• Assessment of significance of changes.
• Prepare and submit technical and administrative documents to authorities such as, but not limited, to Health Canada, FDA and European Authorities.
• Prepare new registration files and submit to relevant authorities.
• Liaise with external customers and/or authorities for the renewal and/or maintenance of existing registrations and licenses, and/or for territory extension.
• Act as Subject Matter Expert during regulatory site/certification audits.
• To oversee and/or perform the execution of regulatory assessments of non-conformities and adverse events and inform the relevant competent authorities of any reportable incident and field safety corrective action according to national and local reporting deadlines.
• Support the business in the coordination and execution of field safety corrective actions providing regulatory oversight on such actions. Examples of such actions include not limited to: corrections, removals, withdrawals, etc.
• To contribute to the development and implementation of regulatory policies, procedures and specifications across the company and ensure that these are compliant with the Quality Management System.

Our new Regulatory Affairs Specialist:

• Bachelor / Master degree in physical/biological sciences or engineering or equivalent.
• Preference for 1-3 years’ of experience in Regulatory Affairs and/or Quality Assurance in a medical device company.
• Experience with specific topics such as EU medical device regulations, FDA law, other global medical device regulations and or REACH and RoHS requirements is a pre.
• Demonstrated ability to communicate effectively both verbally and in writing in English and Dutch.
• Advanced skills in Microsoft Excel, Word and Powerpoint.
• Proven good organizational skills.
• High self-motivation.

Why would you work for us?

You will be part of the growing and ambitious environment of the Welcony group. A dynamic organization in full expansion, internationally oriented and with an absolute drive to maintain the energy and atmosphere of a small organization. We value a hands-on approach and allow you to excel, develop, create and implement your own expert knowledge that can be converted to the best results. We support our employees to further develop their competences and interests. We are a down-to-earth, results driven organization with short lines of communication and quick decision making. We have an ambition and passion to become a strong leader in the medical world. And want to realize this with the best people and breakthrough innovations.

Package:

Neurosign/Technomed offers you a challenging position with good career prospects in a fast-growing international company. We also offer a competitive remuneration package and the ability to work partially from home.

Organisation:

Neurosign/Technomed is a global medical device company which is part of the Welcony group, owned by a US private-equity firm. Technomed is a fast-growing leader in medical accessories focused on monitoring electrical signals. Technomed sells branded products, private labeled products, and OEM solutions. Neurosign is one of the market leaders and renowned in the world for its range of Intra-operative Nerve Monitors. We are also producing probes and electrodes which are used in Thyroidectomy, Mastoidectomy, Parotidectomy, Spinal Nerve Root and Skull-base surgery. The products are highly competitive and among the best in the market. Neurosign/Technomed has an open, informal culture with an enthusiastic team and short lines of communication. Responsibility, innovation and creativity form the basis of our growing and learning organization. We take initiative and ownership and love to go above and beyond. We deliver better patient outcome and for us quality is key!

How to apply

Interested in this position at Technomed? Please send your CV and motivation letter by submitting your application by using our Online Application Form For questions and more information about the Regulatory Affairs Specialist Neurosign / Technomed vacancy, please contact Jefte Erens (Global HR Director) on phone number +31(0)43-4086878 Website: Go to website