Parexel are recruiting for a Principal Consultant to join our Parexel Consulting Regulatory team. You can be homebased anywhere in the UK.
• 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.
• Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, PhD or other advanced degree (i.e. MBA) preferred.
Minimum Work Experience:
• Numerous years’ experience with expert level industry or regulatory knowledge experience with a regulatory agency (such as FDA, MHRA) specialising in Medical Devices.
• Prior experience working for an Agency or Notified Body is a strong positive
In return we will be able to offer you a structured career pathway and development within the role including awareness and understanding of the industry. Your hard work will be rewarded with a competitive base salary, company car/car allowance, bonus scheme and benefits package including 25 days holiday per year, private dental and medical insurance, a strong contributory pension scheme, and many more flexible benefits for you to select.
Apply today to begin your Parexel journey!