Hiring Director of Regulatory Compliance & Quality Assurance at Kinamed, Inc.

Director of Regulatory Compliance & Quality Assurance 
Salary: Open
Employer:  Kinamed Inc
Location: Camarillo, CA (onsite)
Type: Full Time – Experienced
Discipline: Regulatory/Quality
Sector: Private Industry
Required Education: 4 Year Degree

About Kinamed Inc
Kinamed is a small, privately-held medical device company with a seasoned management team and an experienced workforce. We are fully integrated, focusing on implants and instruments used in orthopedic surgery, cardiothoracic surgery, and neurosurgery. Our devices are sold in >30
countries throughout the World. We look for qualified individuals who enjoy working with a passionate team on innovative devices used in orthopedic surgery.

Job Description
The position is primarily responsible for interpreting and maintaining compliance with applicable US FDA and ISO 13485 medical device regulations, as well as particular requirements of other international regulatory agencies, at all levels of the organization. It requires the application of practical experience and a technical knowledge base for developing, implementing, and leading the regulatory and quality control systems within defined regulations to meet strategic and day to day objectives. It requires both attention to detail and process considerations in execution of responsibilities. This position has direct reports, and reports directly to the Company’s President & CEO. 

This role is ideally suited to a candidate who is self-motivated and excited by an opportunity to rise to frequent and diverse challenges.

 Requirements:

• A bachelor’s degree in a scientific or technical discipline with six years of related industry experience in quality and regulatory affairs in a 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 the MDD and MDR. Knowledge of quality/regulatory requirements of various foreign bodies such as Japan PMDA, China NMPA, Australia TGA is beneficial.
• Experience in preparing for and hosting FDA inspections and Notified Body audits.
• 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 quality/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.