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Job Details

Regulatory Affairs Specialist (Medical Devices) - Home based UK/EU - Permanent.

Company: Novella Clinical Resourcing
Location: Home based UK/EU
Reference: NC172352 Regs Spec
Closing Date: 16 Jun 18
Type: Permanent
Salary (£): On Application
Benefits: Benchmarked benefits

Job Summary:

Regulatory Affairs Specialist with a strong background in Medical Devices required by Novella Clinical, a Quintiles company. This role is full time, permanent and home based in UK or EU.


A Regulatory Affairs Specialist (MD&D) is required by Novella Clinical, a Quintiles company. Novella is a global, full service CRO with our European Headquarters in Hertfordshire, England. We are committed to providing a superior service to our global clients, and as such we are seeking to hire the best Associates in the industry.  

This vacancy is for a Regulatory Affairs Specialist with good experience in Medical Devices & Diagnostics.

This Regulatory Specialist position is a role that really sets the pace for each and every study. The goal is always to help bring new drugs to market, faster and more efficiently – making a real difference to the lives of patients. It is a role where self-motivation, a dynamic personality and the ability to work with, and lead a wide variety of highly-skilled professionals can let you develop the career you choose.

Award-winning and innovative, our projects have the size and reach to help you grow professionally. The role also offers a greater level of flexibility than many, with home-based or office working as options. There is also flexibility around working hours, as many projects require work across different international time zones. Yet at the same time, even if you are home-based, we make every effort to ensure a supportive team environment.  

Whilst projects vary, your typical responsibilities might include:

·       Directing and managing the delivery of all required start-up, maintenance and regulatory activities for selected studies as determined by either the agreed algorithm or the Sponsor’s (customer’s) requirements

·       This includes pre-award activities, oversight of the scope of work, budget and resources

·       Developing and implementing the RSU Management Plan

·       Ensuring collaboration across RSU, including communication with regions and countries

·       Assisting with the creation and review of core scientific, technical and administrative documentation

·       Contributing to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence

·       Ensuring overall project efficiency and adherence to project timelines and financial goals

You will need to be comfortable negotiating, collaborating and communicating with a variety of colleagues and customers – including project and clinical leads. Ideally, you will also have an understanding of clinical research, project management and drug development. Good time management and attention to detail are also essential skills.


Requires Bachelor's degree with at least 3 years of regulatory work experience, science degree preferred or equivalent level of education and work experience.

Excellent analytical and communication skills, particularly writing skills, are essential. 

Demonstrated computer literacy is required. 

Ability to travel a minimum of 20% both domestically and internationally is required.


•             Working knowledge of and aptitude for activities related to regulatory affairs and quality assurance, both domestic and international. as it pertains to Medical Device studies.

•             Experience interacting with regulatory agencies is preferred.

•             Ability to understand and communicate regulatory requirements for different therapeutic areas and countries and associated submission pathways.

•             Familiarity with or ability to become familiar with regulatory documents, general contents, organization and the methods of filing and tracking.

•             Familiarity with or ability to become familiar with principles of Good Clinical Practice, Good Laboratory Practice and Good Manufacturing Practice., ISO standards.

•             Extensive knowledge of clinical research; knowledge and familiarity with 21CFR11 and EDC systems.

•             Experience in preparation of audit plans and checklists against applicable standards, execution of audits, and preparation of comprehensive written audit reports.

•             Good interpersonal skills with the ability to communicate effectively, both orally and in writing, with all levels of staff, and with the public. 

•             Ability to be detail oriented with background adequate to deal with scientific issues related to technical regulations and SOPs.

•             Ability to read and synthesize technical material and to prepare clear and concise written documents.

•             Computer literate at a level allowing utilization of event tracking programs, data loading and information processing related to regulatory affairs and quality assurance.

This Regulatory Specialist role offers a competitive salary and bench marked benefits package. The role can be home based in the EU or UK or office based in Stevenage.

To apply please submit a CV in Word format.


Key words: Regulatory Specialist, Regulatory Affairs Specialist, MD&D, Medical devices. Medical Devices regulatory specialist.

Apply for this job: Regulatory Affairs Specialist (Medical Devices) - Home based UK/EU -  Permanent.

Contact Information:

Address:  Novella Clinical Resourcing
Ground Floor, Abel Smith House, Gunnells Wood Road, Stevenage, Hertfordshire
Tel:  +44(0)1438 221122
Fax:  +44(0)870 762 6257
Website:  Visit Our Web Site

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