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Deputy Regulatory Affairs Manager(UK)

Kimal plc
Job LocationBromsgrove
EducationNot Mentioned
SalaryCompetitive salary
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent , full-time

Job Description

Kimal is an innovative and trusted manufacturer with a global presence and supplier of specialised procedure packs and vascular access devices to hospitals across the world. We are proud of our achievements and we strive to continuously improve in all aspectsof the products and service we give to our worldwide base.If you are a regulatory professional with experience and the aim to eventually become a manager, joining our dynamic team is for you! You will assist the Regulatory Manager in managing ongoing projects and will gain solid experience which will allow youto take the next step on your career ladder.Our product portfolio ranges from Class I to Class III products and spans cardiovascular, haemodialysis and surgical procedure products and we can guarantee comprehensive regulatory exposure to all regulatory specialities. The focus of this team is to successfullytransfer our entire product portfolio to Medical Device Regulation compliance by 2024 and you will be involved in all aspects of such compliance.You will also have the exposure to preparation of 510k FDA applications and various other country registrations although this is not the focus of our team currentlyYou will be required to assist the Regulatory Manager in leading a team of young regulatory professionals and will regularly interact with product managers, other department managers and clinicians to ensure the following reports are generated for regulatorysubmissions:

  • Biocompatibility planning and managing test results.
  • Clinical evaluation report compilation as part of a team of experts
  • Post market clinical follow up.
  • Compilation of MDR compliant Technical documentation
  • Post market surveillance reports
  • Systematic literature searches
  • Risk Management activities and reporting
As part of the Kimal team you will help translate real- world product manufacturing scenarios into review ready reports and technical files. Our offices are in close proximity to the manufacturing site, and you will be able to interact directly with manufacturingteams to gain an understanding of the technical and quality product requirements and processes, which will be needed to compile the required technical documentation.The Kimal regulatory team pride ourselves in being a true cross functional team and as part of our day-to-day functions we support other departments including:
  • Specifications
  • Quality
  • Technical
  • Marketing
  • Labelling
  • Quality
  • Manufacturing
  • Research and development team
We see regulatory as an interactive and important key to patient safety and we do not view our department as paper-pushers. Therefore, if you are a process driven person, with a keen understanding of medical device regulations and requirements, this is theposition for you. You will help lead a hands-on team that loves to interact and learn from other teams.Candidates must hold a scientific degree with a minimum of 2 years in a Medical Device Environment and withinregulatory. Management experience is not critical but will be beneficial and you must be willing to lead and mentor less experienced team members.Excellent problem-solving skills, teamwork and attention to detail is a must.This role is predominantly home based, with the requirement to have minimum office presence.In return, we can offer a competitive salary, pension, 25 days holiday which increases with service, private healthcare, life assurance, holiday purchase scheme and a flexible benefits platform.

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