Your role as Sr. Regulatory Affairs Specialist:
Technomed’s medical accessories connect medical devices to patients and transfer their bio-electric signals. Technomed is an expert in the medical accessory industry. We provide standard products and private labelling.
As Sr. Regulatory Affairs Specialist you play a key role in processes that ensure patients safety and regulatory compliance of all Technomed medical devices and accessories. You are also co-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 also act as the regulatory expert, setting regulatory requirements, regulatory strategy and plan to allow worldwide registrations for new products. You will interact with numerous internal and external customers worldwide including local representatives. You will coach junior RA specialists; helping to answer various regulatory related questions.
You will take ownership for the review and maintenance of the registration files according MDR and Worldwide requirements. You will inform relevant competent authorities of any reportable incidents and field safety corrective actions if required.
For this role we prefer you to be in the office, but working from home can be discussed.
Your responsibilities are:
• Contribute to the development and implementation of regulatory plans which ensures regulatory requirements are met and maintained throughout the product lifecycle, including new products and modified products;
• Develop and maintain Technical Documentation Files in accordance with the EU regulation and applicable jurisdictions;
• Prepare or review regulatory documentation that may include, but not limited to biological evaluation reports, clinical evaluation reports, and summaries of objective evidence of compliance with the General safety and performance requirements;
• Plan, generate, and coordinate worldwide regulatory submissions for product licensing, and maintenance of existing regulatory licenses, including change submissions;
• Provide senior regulatory support to product development teams throughout the design control process, including the analysis of applicable standards, guidance on risk assessment and effective implementation of the regulatory plans;
• Review the impact of changes to standards and regulations, assisting with any required conformance and engineering change activities;
• Independently manage multiple projects, department initiatives, and day-to-day tasks.
Our new Sr. Regulatory Affairs Specialist:
• Minimum of Bachelor’s degree in physical/biological sciences or engineering or equivalent;
• Broad depth of worldwide medical device registrations;
• At least 5 years in a medical device company with EU class IIa (or above) devices;
• Experience with successful preparation and submission MDR files and /or US 510(k) is desirable;
• Strong background in Design Controls and related technical documentation;
• Working knowledge of medical device regulations MDR, FDA Law, other global laws and regulations including good understanding or REACH and ROHS requirements and how to implement efficiently all applicable regulatory requirements;
• Experience in medical device accessories is highly desirable;
• Experience in coaching junior staff is desirable;
• Demonstrated ability to communicate effectively in English both verbally and in writing;
• Proven organisational skills;
• Stress resistant;
• High self-motivation.
Technomed offers you a challenging position with good career prospects in a fast-growing international company.
Technomed is a global medical device company part of the Welcony group, owned by a private-equity firm.
We produce accessories which connect medical devices to patients and transfer bio-electrical signals, mainly in the field of Clinical Neurophysiology, Intra Operative Neuro Monitoring and Multi Electrode adhesive patches. We have an own range of neurodiagnostic accessories which are distributed worldwide.
We have been around for more than 30 years and the future looks bright with many growth opportunities. Our headquarter is near Maastricht-Airport, with production subsidiaries in Bandung, Indonesia and worldwide distribution.
Welcony is a global leader in neurotechnology supporting thousands of research labs, clinics, hospitals and universities focused on mental health, brain disorders, cognitive neuroscience and neuromonitoring. Namely, our products transform a bioelectrical signal from the patient to medical devices to measure the nervous system's brain and muscle activities.
The Welcony includes 4 brands with one mission: "Bringing the best minimally invasive neurotechnology to the market for researchers, clinicians and patients."
Our brands are:
Magstim - Transcranial Magnetic Stimulation (TMS)
MagstimEGI - High-Density EEG
Technomed - Clinical Neurophysiology
Neurosign - Neuromonitoring.
How to apply for this career opportunity?
We appreciate hearing from all qualified candidates by submitting your application by using our Online Application Form. For questions and more information about the Senior Regulatory Affairs Specialist (Office / Home-office) vacancy, please contact Mr. Guy Laeven Laeven (Interim Recruitment Consultant) on phone number +31619798068. Website: Go to website
|Title||Senior Regulatory Affairs Specialist (Office/ Home-office)|
|Job location||Amerikalaan 71, 6199 AE Maastricht-Airport|
|Published||August 13, 2021|
|Job types||Researcher  |
|Fields||Electromagnetism,   Biomedical Engineering,   Physiology,   Neuroscience,   Biomedicine,   Clinical Sciences,   Biophysics,   Molecular Biology,   Medical Technology,    and 2 more. Medical Physics,   Signal Processing  |