EDUCATION/ TRAINING and/ or EXPERIENCE:
· Masters Degree or Equivalent.
· Requires 10 - 15 years related experience, predominantly in Regulatory with a minimum of five within the therapeutic space. Must have taken product through the complete regulatory cycle (development to commercialization).
· PMA experience required and Class I, II and III Medical Device experience.required
· International Regulatory experience in EMEA, APAC and LATAM regions preferred.
· Can work in a fast paced environment.
· Significant management and people management is required.
· Strong interpersonal communication skills.
REQUIRED KNOWLEDGE, SKILLS, ABILITIES and CERTIFICATIONS/LICENSES:
· Ability to use PC’s and associated software
Good written and oral English communication skills required
ADDITIONAL POSITION REQUIREMENTS Include whether or not position will be required to work in clean room, near or with heavy machinery, ability to lift heavy objects, ability to wear protective gear in lab, etc
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The noise level in the work environment is usually quiet.
Travel required (approximately 35%), predominantly US and EU in nature.
GENERAL PROVISIONS:
Company management reserves the right to add, delete or otherwise alter assigned duties at any time. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The minimum qualifications listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The above statements are intended to describe the general nature and level of the work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.