Our Client is an established, privately-held medical device company with a seasoned management team and incredible company culture. They are fully integrated, focusing on cutting-edge implants and instruments used in orthopedic surgery, cardiothoracic surgery, and neurosurgery. Their devices are sold in >30 countries throughout the World and counting.
Job Description:
The position is primarily responsible facilitating regulatory approvals globally with an emphasis on CE Mark under EU MDR. This role will also focus on interpreting and maintaining compliance with applicable US FDA and ISO 13485 medical device regulations. The position requires the application of practical experience and a technical knowledge base for developing, implementing, and leading the regulatory efforts to meet strategic and day to day objectives. It requires both attention to detail and process considerations in execution of responsibilities. This person will lead a small team and report directly to the Company's President & CEO.
Requirements: • A bachelor's degree in a scientific or technical discipline with six plus years of related industry experience in regulatory affairs preferably within an cGMP orthopedic implant environment. • Detailed knowledge of and experience with US FDA and ISO 13485 regulations, as well as the quality/regulatory requirements for obtaining and maintaining the CE Mark under MDR. Knowledge of quality/regulatory requirements of various foreign bodies such as Japan PMDA, China NMPA, Australia TGA is beneficial. • Hands-on experience with the preparation and submission of 510(k), Technical File/Document, and other international registration dossiers. • Responsible for training the staff on regulatory requirements which pertains to their position. • Knowledge and experience with CAPA processes. • Responsible for being the Management Representative and PRRC. • Enthusiasm for being a hands-on contributor in all aspects of job function. • Self-motivated, self-directing, strong attention to detail and excellent time management skills. • Strong interpersonal and management skills with the ability to communicate effectively both verbally and in writing. • Experience in smaller company environments where multi-tasking skills are essential. • RAC certification is beneficial. • Orthopedic implant / Instrumentation highly preferred.