The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
The Regulatory Affairs Program Manager is responsible for managing U.S. and global regulatory pre-market submissions and other pre-market filings to acquire and maintain appropriate commercial distribution clearances for specific Orthofix product families / technologies. The Regulatory Affairs Program Manager is a key partner to the Research & Development and Marketing teams in achieving new product development and commercialization.
What will be your duties and responsibilities?
Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
Prepare and maintain domestic product submissions including FDA 510(k), PMAs, and PMA annual reports
Prepare and maintain global product submissions including international registrations and license applications
Prepare and maintain Technical Documentation to support product CE-marking
Develop regulatory strategies for new products.
Provide regulatory affairs support to project design teams
Review and approve product labeling
Review design and/or process changes and assess regulatory implication relative to the change
Provide regulatory support for product and quality system related changes
Provide regulatory affairs support during FDA inspections and Notified Body audits
Provide regulatory affairs guidance to other Orthofix departments, as necessary
Provide support for the company’s transition from EU MDD to EU MDR
Help drive process and compliance improvements activities
What skills and experience will you need?
Bachelor's degree (science or technical preferred)
10+ years of experience in Regulatory Affairs, specifically in the medical device industry
Experience with implantable orthopedic devices.
Demonstrated knowledge of FDA QSR, ISO 13485, EU MDD, EU MDR, CMDR and global submission requirements
Strong attention to detail and the ability to multitask
Excellent oral and written communication skills
Ability to prioritize, conduct team meetings, and meet project deadlines
Public speaking proficiency
Willing to mentor others
What skills would be helpful?
Regulatory Affairs Certification (RAC)
Experience with electrical medical devices and associated IEC standards
Internal Number: OFX20192
HEALING BONES. HEALING LIVES
Orthofix International began in a small farmhouse in Verona Italy in 1980 when orthopedic researcher Giovanni De Bastiani recognized the bone’s natural repair capability, a concept he called “dynamization” and with that in mind, he created the first external fixation device.
Today, Orthofix has grown to more than 900 employees with locations in the U.S., Italy, Germany, France, the UK, Brazil, Australia and Puerto Rico. Our products help patients in 70 countries around the world.
Orthofix is comprised of four strategic business units; Biostim, Biologics, Extremity Fixation and Spine Fixation. Our products are widely distributed via the company's sales representatives, distributors and subsidiaries.
At Orthofix we are committed to clinical research and driven by new product introductions. We are proud of our strong partnerships with organizations such as the Texas Scottish Rite Hospital for Children in Dallas and the Musculoskeletal Transplant Foundation. We take pride in developing superior products and providing world class education for surgeons and field-based Orthofix personnel supporting them around the world.
Orthofix makes a di...fference in the lives of our patients by providing our surgeon customers with innovative medical devices to meet the needs of their patients. Every day we are optimizing our operations, improving efficiencies and examining our systems to provide the best support possible to our representatives, surgeons and patients.