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Global Regulatory Affairs Manager

Employer
Magstim
Location
Whitland, Carmarthenshire (Sir Gaerfyrddin) (GB)
Salary
Competitive
Start date
3 Jul 2021
Closing date
2 Aug 2021

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Your role as Regulatory Affairs manager;

Magstim is a global medical device organisation with facilities in the UK and the United States. Globally, Magstim technologies have supported thousands of research labs, clinics, hospitals and universities that focus on mental health, brain disorders, cognitive neuroscience and neuromonitoring. Products range from capital equipment, software to accessories.

We are looking for an experienced Global Regulatory Affairs Manager with a Medical Device background. 

You will be responsible for providing leadership and strategic direction of the Regulatory function, ensuring the Company and its products, complies with all relevant regulatory requirements for all products in each territory into which it operates.

You will report directly to the Chief Quality and Regulatory Affairs Officer who is also based at our location in Whitland/ UK. You will have to manage a department, currently existing of 3 employees but will most probably double in size in the near future. 

The interesting part of this role as Regulatory Affairs Manager you will be involved in the total life-cycle of our products; from concept, to implementation, to maturity, to phase out. 

We are looking for a candidate who has Regulatory affairs experience in the full product life-Cycle in the Medical Device Industry. Someone with regional but preferably global experience. Are you able to work under pressure, highly motivate, keen in leading and motivating others, than we would like to receive your resume.

This is a hybrid home- and Office-Based role in Whitland, UK. Also some travelling will be involved.

Magstim is rapidly growing company with an impressive product portfolio and aggressive pipeline. 

Your responsibilities are: 

  • Providing proactive leadership to the regulatory team;
  • Fulfilling the role as person responsible for regulatory compliance, with including duties:
    • ensuring that the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released;
    • ensuring that the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; 
    • ensuring that the post-market surveillance obligations are complied; 
    • ensuring that the reporting obligations are fulfilled; 
    • ensuring that in the case of investigational devices, the statement is issued;
  • Executing the regulatory strategy, including but not limited to NPD, NMI and regulatory landscape changes;
  • Representing Magstim in regulatory matters to influence outcomes and establish strong and valuable partnerships, including communicating with regulatory and governmental agencies;
  • Planning, directing and controlling all regulatory activities supporting the introduction of new products, modification or withdrawal of existing products;
  • Overseeing the process of preparing product submissions to domestic and international regulatory bodies and leading the process from inception to approval;
  • Defining, implementing and managing regulatory initiatives;
  • Maintaining awareness of current and new regulatory requirements for all territories in which Magstim operates and ensuring executive management is informed;  

Our new Regulatory Affairs Manager:

  • Minimum 5 years of experience in senior regulatory roles in the Medical Device industry;
  • Experience in managing a team;
  • Degree in law, medicine, pharmacy, engineering or another relevant scientific discipline;
  • Advanced knowledge of EU Medical Device Regulation (2017/745), US FDA regulations (Code of Federal Regulations, Title 21), Canadian Medical Device Regulation (SOR 98-282) and all relevant harmonised / recognised standards;
  • Positive, driven and highly motivated with the ability to lead and motivate others;
  • Team player and ability to work with deadlines;
  • Flexible & adaptable with capability and willingness to embrace change;
  • Strong external customer focus and internal influencing and networking skills; 
  • Excellent organisational skills and ability to lead projects involving multi-disciplinary teams; 
  • Good written and oral communication in English;
  • Computer skills including Microsoft Word, PowerPoint and Excel.

Package:

Magstim offers you a challenging position with good career prospects in a fast-growing international company. We also offer a very competitive remuneration package.

Organisation:

Magstim is a private global medical device company that is part of Welcony Inc. with more than 330 employees world-wide. Welcony Inc. technologies have supported thousands of research labs, clinics, hospitals and universities that focus on mental health, brain disorders, cognitive neuroscience and neuromonitoring. Key brands include Magstim Magnetic Stimulation capital equipment, MagstimEGI high-density EEG software and capital equipment, Technomed Clinical Neurophysiology consumables and Neurosign Intraoperative Nerve Safety Monitoring capital equipment and consumables. 

How to Apply:

If you are interested and you meet all the above requirements please send your resume via the apply button to Magstim. For more information about this position, please contact Guy Laeven at Magstim via +31 619 798 068 (www.welcony.com / www.magstim.com)

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