Vice President, Regulatory Affairs & Quality Assurance

Our client manufactures and distributes a rapidly growing line of spinal products and specializes in co-developing spinal implants and instruments with surgeons. It is one of the highest growth companies in the orthopedic device industry.

 

The Company?s focus on research and development allows for a competitive advantage with its ability to design and manufacture orthopedic devices that have design advantages. As a result, the company?s products simplify surgical procedures, improve clinical results and ultimately reduce the cost of quality medical care. The Company works closely with many prominent orthopedic surgeons, including surgeons who enjoy national and international reputations in developing products.

 

With corporate headquarters located in Carlsbad, California, the company has worldwide sales capability and a powerful distributor network.

 

The Vice President of Regulatory Affairs and Quality Assurance will report to the Chief Technical Officer.  The position is responsible for all Regulatory and Quality Assurance activities within the Company and will ensure the regulatory and quality compliance of its suppliers / vendors.  Specifically, the Vice President of Regulatory Affairs & Quality Assurance will be responsible for and participate in the following activities:Managing a small team of Regulatory and Quality Assurance professionals and successfully navigating a complex device approval process with outside agencies.  Working with the regulatory agencies to assure compliance with government regulations regarding all aspects of development and manufacturing.  Attending the development staff meetings to help oversee product testing and contribute to organizational discussions. Providing regulatory and quality oversight for all aspects of manufacturing and controls.  Working in partnership with GCP and cGMP vendors especially with regard to training and documentation review.  Seeking competitive superiority by leveraging knowledge of regulatory and quality requirements to guide the technical aspects of the development process and to achieve the desired action in the shortest period of time. Providing guidance and advice to senior management and staff in order to achieve goals related to regulatory timelines, product testing, quality assurance, and manufacturing processes and methods.  Establishing work practice guidelines to achieve optimal resource utilization and streamline dossier preparation across contributing departments.  Directing regulatory and quality strategy related to product development operations and testing programs. Implement and manage systems to audit, evaluate and approve the policies, procedures and practices impacting the cGMP operations of the Company. Direct all activities for regulatory compliance within new business opportunity projects.  These include quality agreement, validation, audit and site transfer activities. Direct programs to audit and implement follow-up actions to ensure that external supplier of components, packaging supplies and contract manufactured goods are in conformity with regulatory agency commitments and requirements (e.g., MMF?s, SOP?s, etc.). Ensure that the regulatory and quality affairs unit reviews and approves all validation protocols / summaries so that documented evidence is available to demonstrate that the Company?s products, processes, equipment and facilities can consistently perform as they are required. Review and oversee the training performed within the various operational areas so that persons engaged in GMP functions have the adequate education, experience and / or training to perform the functions to which they are assigned. Establish and lead by example a zero tolerance regulatory and quality policy and attitude to insure the highest standard of quality throughout the Company. Participate as a member of the site management team to coordinate all regulatory and quality affairs activities for new and existing products. Review and approve appropriation requests for all manufacturing and packaging equipment for any equipment purchases affecting product quality. Plan and administer the manpower, expense and capital budgets.  Monitor performance and take actions to correct deviations from the budget.

 Qualifications

 

The ideal candidate will have a strong regulatory and quality background.  He/She should possess a minimum of 10 years of regulatory / quality experience in the Pharmaceutical or Medical Device industry.  The successful candidate will have experience in the preparation and assessment of regulatory filings in the U.S.  The successful candidate must have strong regulatory knowledge of device development, clinical trial requirements, design and analysis, post-marketing surveillance, manufacturing, quality, marketing and sales.  Experience corresponding with regulatory bodies is necessary.

 

This Vice President of Regulatory Affairs and Quality Assurance must have the stature/experience to quickly gain confidence both within the Company?s fast moving environment, as well as externally with regulatory agencies.  He/She must be high energy, flexible in approach, entrepreneurial by nature and be a team player who is willing to roll up their sleeves and contribute at all levels.  He/She will be a strong, organized leader with strategic vision who sets clear goals and is results-oriented.  Furthermore, this individual will possess the characteristics generally associated with a senior executive: strong communication skills, ability to lead/influence, impeccable ethics and judgment.