Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms

Pharmiweb.com RSS Feed Pharmiweb.com RSS Feeds

Job Details

Principal Regulatory Affairs Consultant - EU Medical Devices SME

Company: PAREXEL
Location: United Kingdom
Reference: 40217BR
Closing Date: 09 Jan 19
Type: Not Specified
Salary (£): Competitive
Benefits:

Job Summary:

The role can be office or home based in many of our EMEA locationsJob Description: A Principal Consultant must be a nationally recognized professional in their field of expertise with well-developed and proven rainmaking skills. A Principal Consultant must have a comprehensive understanding of the organization’s consulting models and methodologies, as well as, an extensive knowledge of what services PAREXEL Consulting provides. ...

Requirements:

The role can be office or home based in many of our EMEA locations

Job Description:

A Principal Consultant must be a nationally recognized professional in their field of expertise with well-developed and proven rainmaking skills. A Principal Consultant must have a comprehensive understanding of the organization’s consulting models and methodologies, as well as, an extensive knowledge of what services PAREXEL Consulting provides. A Principal Consultant provides a full range of consulting services and works within their personal area of expertise. A Principal Consultant provides mentoring and guidance to junior team members on technical and/or business issues and supports knowledge-centered activities within PC.

We are currently seeking an EU Medical Devices SME , aligned with the following profile:

• Senior regulatory/clinical professional with specialized expertise in the regulation and clinical development of medical devices in European markets.
• Specific knowledge of the text and associated implications of the new European Medical Devices Regulation (MDR)
• Direct experience with driving medical device approvals (CE marking) in European markets, including specialized knowledge of design validation and verification procedures for medical devices.
• Experience in developing clinical development strategies for medical devices and assessing conformance to international standards.
• Working knowledge of all phases of medical device product development, including early design, risk analysis, product verification and validation, manufacturing, labeling etc.
• Recognized technical subject-matter expertise specific medical device field (e.g., in vitro diagnostics, imaging, orthopedic implants, cardiovascular devices etc.).
• Established experience in leading teams and collaborating with sponsors/clients in resolving challenges in medical device product development.




QualificationsEducation:

• Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, PhD or other advanced degree (i.e. MBA) preferred.

Language Skills:

• At least fluent vocal and written English

Minimum Work Experience:

• Numerous years’ experience with expert level industry or regulatory knowledge experience with a regulatory agency (such as FDA, MHRA) is a plus.
• Prior experience working for an Agency or Notified Body is a strong positiveEducation:

• Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, PhD or other advanced degree (i.e. MBA) preferred.

Language Skills:

• At least fluent vocal and written English

Minimum Work Experience:

• Numerous years’ experience with expert level industry or regulatory knowledge experience with a regulatory agency (such as FDA, MHRA) is a plus.
• Prior experience working for an Agency or Notified Body is a strong positive

Apply for this job: Principal Regulatory Affairs Consultant - EU Medical Devices SME

Contact Information:

Address:  PAREXEL International
The Quays
101-105 Oxford Road
Uxbridge
Middlesex
UB8 1LZ
England
Tel:  +44 1895 238000
Fax:  +44 1895 238494
Website:  Visit Our Web Site
Advertisement

Advertising
Site Map | Privacy & Security | Cookies | Terms and Conditions

PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.