JOBS IN PLASTICS, MEDICAL DEVICE AND PACKAGING

CLINICAL AFFAIRS MANAGEMENT JOBS

Clinical Affairs Director

Our client is a rapidly growing international medical device manufacturer.  New products currently in development will soon be ready for clinical testing and we seek an experienced Director of Clinical Affairs to organize and manage the Clinical Affairs function.  We seek a senior executive with exceptional skills in all aspects of managing clinical trials, marketing, and product management support.  If you are seeking a once in a lifetime opportunity offering significant career growth - present your resume to us Today!

Responsibilities:

The Director of Clinical Affairs will be responsible for managing a staff of skilled and dedicated professionals, organizing and establishing departmental operating systems and protocols, providing technical guidance and support to internal departments as well as external partners and distributors, ensuring compliance to industry regulatory requirements, and the completion of accurate clinical evaluations of company products.

Duties will include:

• Manage the organization and establishment of Clinical Affairs departmental operating systems including personnel selection, training and development, and performance evaluation; establishment of standard operating procedures; and development and administration of department budget.
• Develop protocols and manage clinical user evaluations for the Company’s products. 
• Participate in the assessment of new products and conduct market research to evaluate potential designs based on user requirements and expectations.
• Assist Regulatory Affairs to ensure compliance to industry regulations regarding product packaging and marketing.
• Provide technical support and clinical trial data to assist in review of customer complaints in conjunction with Quality Assurance, Regulatory Affairs, and Marketing.
• Attend industry Trade Shows, Technical Conferences, and other events to promote and demonstrate company products.

Requirements include

• Minimum requirement for a Bachelor’s Degree in Nursing (or certification as a Registered Nurse).  Bachelor’s degree in a related field with clinical experience will be considered.
• At least 5 to 10 years of experience managing clinical affairs for medical device or pharmaceutical companies.
• Specific skills and experience in the conduct of clinical trials and demonstrated technical understanding of clinical trial protocols in the United States and European Union required.
• Must be bilingual:  German (highly preferred) or French
• Must have a current passport and ability to travel up to 50% to both domestic and international locations.

Compensation:

• Client offers a highly competitive starting salary and executive bonus.  In addition there are excellent benefits including Medical, Dental, Vision, Life and Disability insurance; 401k (generous matching); paid holidays and personal days; and an outstanding relocation package.

• There is a potential for equity participation.

   

Apply Now!

Please email your resume in Word Format to Roger Aistrup at: jobs@allanjamesassociates.com