Ensure domestic and international regulatory submission and reporting activities are completed in a timely manner so that full compliance with all applicable global regulatory requirements and internal product/project goals is maintained.
DUTIES AND RESPONSIBILITIES (essential functions of position):
Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
Prepare domestic and international product submission and reports including: U.S. FDA 510(k)s, IDEs, PMAs, annual reports, supplements, international product registrations, MDRs, Vigilance Reports and Problem Reports.
Prepare and maintain Technical Files with state-of-the-art requirements.
Assist with preparation of CER, PMCF, PMS, and other required vigilance reports and submissions and updates.
Support the company’s transition from EU MDD to EU MDR.
Prepare and review product labeling.
Prepare correction and removal (recall) reports and coordinate recall related activities.
Provide regulatory affairs support/planning to project teams.
Develop regulatory strategies for new products.
Review design changes and assess regulatory implication relative to the design change.
Provide regulatory support for quality system related changes i.e. ECOs, NCMRs, etc.
Help drive process and compliance improvements activities.
Lead health hazard evaluations to determine risk associated with post-market product issues.
Provide regulatory affairs support during external inspections (FDA, Notified Body, etc.).
Provide regulatory affairs guidance to other Orthofix departments, as necessary.
Regular attendance required.
Other duties as assigned.
PHYSICAL DEMANDS AND WORK CONDITIONS:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Regularly required to sit for extended periods of time; frequently required to stand, walk and use business equipment daily such as P.C., copier, fax, telephone, etc.; occasionally required to reach overhead, bend, and lift objects of up to 20 lbs.
Eyesight and hearing must be correctable to standard level.
Travel required 5-10%; therefore, must be able to utilize airplane, taxi, car, etc.
ESSENTIAL SKILLS, EXPERIENCE AND QUALIFICATIONS:
College degree or equivalent work experience in Regulatory, Quality or R&D. Science or technical degree is preferred.
Minimum of 5 years’ experience in Regulatory Affairs.
Experience with FDA QSR requirements, ISO 13485, and EU Medical Device Directive regulatory requirements.
Excellent oral and written communication skills.
Demonstrate strong attention to detail.
Public speaking proficiency.
Willing to mentor others.
Ability to prioritize, conduct team meetings, and meet project deadlines.
RAC certification, experience with ISO 14971 and experience with US and EU Class III orthopaedic implant devices are preferred.
Internal Number: R0000936
About Spinal Kinetics, an Orthofix Company
Founded in 2003, Spinal Kinetics is a privately-held medical device company focused on partnering with spine surgeons to develop innovative and practical motion preservation systems for treating degenerative diseases of the spine.
The M6 artificial disc is the first of these non-fusion motion preservation products intended to replicate the anatomic and biomechanical attributes of a natural intervertebral disc. The M6 is the only artificial disc that mimics a natural disc’s design by incorporating an artificial nucleus and annulus into both its cervical and lumbar platforms.