This position leads project teams and/or provides technical effort toward the remediation of technical documentation in support of product registrations in the European Union. The position requires an understanding of medical device markets and regulations. This position requires strong leadership and project management experience. The candidate will lead cross-functional teams in an effort to remediate gaps to new EU MDR requirements.
An individual must be able to perform each essential duty satisfactorily. The requirements listed below 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.
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures or government regulations. Ability to write reports and business correspondence. Ability to communicate well with individuals at all levels within (and outside) the organization. Any Spanish knowledge is a plus.
Ability to perform basic engineering calculations and have understanding of design of experiment. Also requires understanding of statistical concepts.
This position requires good judgment. All product and process development activities within a team are to be carried out according to the applicable laws and regulations. When in doubt, the incumbent should source out the appropriate information via internal and external resources.
The incumbent will be a detail oriented individual with the skills to manage multiple priorities, projects and tasks all in support of corporate and divisional goals.
While performing the duties of this job, the employee is regularly required to sit, walk, talk or hear. The employee will sometimes be required to move around in manufacturing facility or meet with medical professionals in hospital environment. Specific vision abilities required by this job include close vision and color vision.
No special work environment conditions other than minimal exposure to manufacturing environment (i.e. noise, minimal heat and some chemical fume exposure), laboratory, and hospital settings.