Medical Device Regulatory Affairs Manager/Associate

The Regulatory Affairs Manager/Associate Director will be responsible for managing and developing TRAC’s medical device regulatory affairs activity. You will be the main contact and expected to work closely with clients, managing medical device regulatory activity, exceeding customer expectations and ensuring that deadlines are met. On occasion you will be expected to deputise for the Regulatory Affairs Director in their absence.

The role will involve expanding TRAC’s medical device service and developing the regulatory team; therefore you will be required to display significant leadership qualities as well as excellent communication and teamwork skills. You will report directly to the Company Directors.

Responsibilities:

• Planning and executing an effective strategy for clients
  setting out timescales and ensuring deadlines are met
• Compilation of the necessary technical documentation
• Managing all aspects of European registrations for new and
  existing products
• Interacting with the appropriate regulatory bodies on specific
  project / product issues as required
• Keeping up to date with European legislation, e.g. attending
  courses, seminars and reading guidelines, directives and articles
• Provide support, training and advice to the RA team concerning
  CE marking and other medical device regulatory requirements
• Assisting in client development activities
• Demonstrate strategic thinking, including the ability to
  integrate overall business objectives into the goals/vision/values of the department and communicate these effectively.

Essential Skills:

• Regulatory experience and proven application of skills within the Medical Devices or IVD industry
• Good understanding of European regulations, procedures and guidelines
• Proven project and people management skills
• Demonstrable leadership skills
• Excellent written and verbal communication skills
• Solid commercial awareness of the impact of the commercial
  environment on the regulatory affairs function
• Proven client relationship management skills
• Ability to work both independently with minimal direction
• Self-motivated, thorough and flexible

Desirable Skills:

• Experience of drug-device and/or pharmaceuticals registrations
• Ability to write articles for journals
• Experience of managing a RA team
• Regulatory strategy development and implementation

Qualifications and Experience:

• A degree in a relevant scientific discipline
• Minimum 5 years regulatory experience within European medical device regulations
• Excellent knowledge of the Medical Devices Directive

Please send a CV and covering letter outlining why you feel you are suitable for the role and stating your current salary to: Sarah Trethowan, Company Director at info@tracservices.co.uk or call 01209 612650 for more information.

Deadline: Closing date for application is midnight Sunday 11th March 2012