Senior Regulatory Affairs Specialist

1 week ago

Oxford, Oxfordshire, United Kingdom Cpl Life Sciences Full time

Senior Regulatory Affairs Specialist – Medical Devices & IVD's

Oxfordshire, UK – Office based

Up to £60,000 + benefits

Make sure to apply quickly in order to maximise your chances of being considered for an interview Read the complete job description below.

This is an excellent opportunity to join a leading medical device manufacturing that is the world leader in Glucose Monitoring, their ranging product portfolio, develops and manufactures glucose monitoring systems for use in both home and hospital settings.

With a diverse, global network serving customers in more than 160 countries, the organisation creates new solutions — across the spectrum of health, around the world, for all stages of life. Whether it's next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, the business is advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.

The business currently has one open positions as a Senior Regulatory Affairs Specialist who will be responsible for planning, creating, and implementing solutions for regulatory registration and release of products for distribution into specific geographies.

Key Responsibilities

  • Lead processes and team involved with obtaining and maintaining product registration, release authorization, and release of products to specified geographies.
  • Driving new registrations in the UK, EU, Middle East, and Pakistan regions.
  • Drive regulatory strategies including working cross-functionally with other departments to ensure the right strategy is defined.
  • Provide training and mentoring to junior colleagues with the scope to get into line management depending on the individual's preference.
  • Interact with notified bodies and keep well-versed in global regulations.

Requirements

  • University degree in a scientific subject, such as Biomedical science, Chemistry, Pharmacy, Engineering, or equivalent experience.
  • Experience working within the requirements of ISO 13485, the Medical Devices Directive (93/42/EEC), and/or the IVD Directive (98/79/EC).
  • Minimum of 4 to 5 years post-qualification experience in regulatory affairs, quality or R&D in the medical device and/or pharmaceutical industry in product registration, medical device file, and/or technical compliance activities.

Due to the organisation's rapid growth, there is extensive opportunity to grow and develop within the company. In addition to a competitive salary, the organsiation offers a highly attractive benefits package that includes a defined-contribution pension scheme, a share ownership scheme, private healthcare, life assurance, and a flexible benefits scheme that you can tailor to your own requirements.

If you are interested in this role or would like more details please email your CV

  • Senior Regulatory Affairs Specialist

    1 week ago

    Oxford, Oxfordshire, United Kingdom TEC PARTNERS LIMITED Full time

    I'm pleased to have partnered exclusively with a market leading and rapidly growing diagnostics company who are focused on developing and commercialising proprietary assays for infectious diseases. Their latest in-vitro diagnostic device has been approvedin over 50 countries where the product is used to diagnose one of the worlds largest cause of death of...

  • Senior Regulatory Affairs Specialist

    1 week ago

    Oxford, Oxfordshire, United Kingdom Perspectum Diagnostics Ltd. Full time

    Senior Regulatory Affairs Specialist About the role The Regulatory Affairs Specialist liaises with the Regulatory Affairs and Quality teams, R&D and Product Management to provide regulatory input into NPI Project Core teams and company operations. They assist in the preparation and submission of regulatory applications and registrations as assigned...

  • Senior Regulatory Affairs Specialist

    1 week ago

    Oxford, Oxfordshire, United Kingdom Cpl Life Sciences Full time £60,000

    Senior Regulatory Affairs Specialist – Medical Devices & IVD'sOxfordshire, UK – Office basedUp to £60,000 + benefitsMake sure to apply quickly in order to maximise your chances of being considered for an interview Read the complete job description below.This is an excellent opportunity to join a leading medical device manufacturing that is the world...

  • Regulatory Affairs Specialist

    1 week ago

    Oxford, Oxfordshire, United Kingdom Oxford Nanopore Technologies Full time

    About UsOxford Nanopore's sequencing platform is the only technology that offers real-time analysis (for rapid insights), in fully scalable formats from pocket to population scale, that can analyse native DNA or RNA and sequence any length of fragment to achieve short to ultra-long read lengths.Our goal is to enable the analysis of any living thing, by...

  • Regulatory Specialist and Senior Specialist

    1 week ago

    Oxford, Oxfordshire, United Kingdom Cpl Life Sciences Full time £60,000

    Senior Regulatory Affairs Specialist – Medical Devices & IVD's Oxfordshire, UK – Office based This is an excellent opportunity to join a leading medical device manufacturing that is the world leader in Glucose Monitoring, their ranging product portfolio, develops and manufactures glucose monitoring systems for use in both home and hospital settings....

  • Regulatory Specialist

    1 week ago

    Oxford, Oxfordshire, United Kingdom GBXB Oxford Immunotec Limited Full time

    Regulatory Specialist (REMOTE or On-site) page is loaded Regulatory Specialist (REMOTE or On-site) Apply locations Oxford, UK - Oxford Immunotec time type Full time posted on Posted 3 Days Ago job requisition id JR Job Title Regulatory Specialist (REMOTE or On-site) Location(s) Oxford, UK - Oxford Immunotec About Us Revvity is a developer and...

  • Senior Regulatory Manager, Clinical Affairs

    4 weeks ago

    Oxford, Oxfordshire, United Kingdom Cpl Full time

    Job Title: Senior Regulatory Affairs and Clinical LeadJob Type: Full time, permanent positionLocation: West Oxfordshire, (On-site) Remuneration: £100,000 +This is an excellent opportunity to join a leading medical device manufacturing that is the world leader in Glucose Monitoring, their ranging product portfolio, develops and manufactures glucose...

  • Senior Regulatory Manager, Clinical Affairs

    1 month ago

    Oxford, Oxfordshire, United Kingdom Cpl Full time

    Job Title: Senior Regulatory Affairs and Clinical LeadJob Type: Full time, permanent positionLocation: West Oxfordshire, (On-site) Remuneration: £100,000 +This is an excellent opportunity to join a leading medical device manufacturing that is the world leader in Glucose Monitoring, their ranging product portfolio, develops and manufactures glucose...

  • Senior Regulatory Manager, Clinical Affairs

    3 weeks ago

    Oxford, Oxfordshire, United Kingdom Cpl Life Sciences Full time

    Job Title: Senior Regulatory Affairs and Clinical Lead Job Type: Full time, permanent position Location: West Oxfordshire, (On-site) Remuneration: £100,000 + This is an excellent opportunity to join a leading medical device manufacturing that is the world leader in Glucose Monitoring, their ranging product portfolio, develops and manufactures glucose...

  • Regulatory Affairs Lead

    1 week ago

    Oxford, Oxfordshire, United Kingdom Lenntech Search Full time

    LennTech Search are working with an innovative software medical device company whom have a need for an experienced Regulatory Affairs Manager. Main Duties Lead company regulatory submissions to the FDA. Preparation of full 510(k) Q-Submissions. Prepare and submit applications and reports to applicable regulatory agencies. Respond to reviews and...

  • Head of Quality Assurance and Regulatory Affairs

    1 week ago

    Oxford, Oxfordshire, United Kingdom Mirada Medical Full time

    About Mirada Medical...Mirada Medical develops medical imaging and cancer treatment planning solutions that provide simple and accessible solutions to complex image analysis problems in the diagnosis and treatment of cancer and other diseases. Our solutions interoperate with other IT systems in the healthcare enterprise, such as EHRs and PACS, empowering...

  • Regulatory Affairs Assistant

    1 week ago

    Oxford, Oxfordshire, United Kingdom PSI CRO Full time

    Company DescriptionWe are the company that cares - for our staff, for our clients, for our partners and for the quality of work we do. A dynamic, global company founded in 1995, we bring together more than 2,700 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who...

  • Senior Research

    1 week ago

    Oxford, Oxfordshire, United Kingdom Proclinical Staffing Full time

    Proclinical is seeking a dedicated Senior Scientist for Analytical Development. This role involves developing and optimising analytical methods to evaluate drug substances and products throughout their development stages. The successful candidate will also coordinate analytical development and analysis work at contract manufacturing organisations (CMOs) and...

  • Senior Analytical Development Scientist

    1 week ago

    Oxford, Oxfordshire, United Kingdom Proclinical Staffing Full time

    Job DescriptionProclinical is seeking a dedicated Senior Scientist for Analytical Development. This role involves developing and optimising analytical methods to evaluate drug substances and products throughout their development stages. The successful candidate will also coordinate analytical development and analysis work at contract manufacturing...

  • Senior Analytical Development Scientist

    1 week ago

    Oxford, Oxfordshire, United Kingdom Proclinical Staffing Full time

    Proclinical is seeking a dedicated Senior Scientist for Analytical Development. This role involves developing and optimising analytical methods to evaluate drug substances and products throughout their development stages. The successful candidate will also coordinate analytical development and analysis work at contract manufacturing organisations (CMOs) and...

  • Senior Analytical Development Scientist

    1 week ago

    Oxford, Oxfordshire, United Kingdom Proclinical Staffing Full time

    Proclinical is seeking a dedicated Senior Scientist for Analytical Development. This role involves developing and optimising analytical methods to evaluate drug substances and products throughout their development stages. The successful candidate will also coordinate analytical development and analysis work at contract manufacturing organisations (CMOs) and...

  • Senior Analytical Development Scientist

    1 week ago

    Oxford, Oxfordshire, United Kingdom Proclinical Staffing Full time

    Proclinical is seeking a dedicated Senior Scientist for Analytical Development. This role involves developing and optimising analytical methods to evaluate drug substances and products throughout their development stages. The successful candidate will also coordinate analytical development and analysis work at contract manufacturing organisations (CMOs) and...

  • Senior Analytical Development Scientist

    1 week ago

    Oxford, Oxfordshire, United Kingdom Proclinical Staffing Full time

    Job DescriptionProclinical is seeking a dedicated Senior Scientist for Analytical Development. This role involves developing and optimising analytical methods to evaluate drug substances and products throughout their development stages. The successful candidate will also coordinate analytical development and analysis work at contract manufacturing...

  • Senior Research And Development Scientist

    1 week ago

    Oxford, Oxfordshire, United Kingdom Proclinical Staffing Full time

    Proclinical is seeking a dedicated Senior Scientist for Analytical Development. This role involves developing and optimising analytical methods to evaluate drug substances and products throughout their development stages. The successful candidate will also coordinate analytical development and analysis work at contract manufacturing organisations (CMOs) and...

  • Senior Research And Development Scientist

    1 week ago

    Oxford, Oxfordshire, United Kingdom Proclinical Staffing Full time

    Job Description Proclinical is seeking a dedicated Senior Scientist for Analytical Development. This role involves developing and optimising analytical methods to evaluate drug substances and products throughout their development stages. The successful candidate will also coordinate analytical development and analysis work at contract manufacturing...