For The Candidates

VICE PRESIDENT, REGULATORY AND QUALITY AFFAIRS

SCOPE:

This newly created, highly visible, leadership position will report to the President and Chief Executive Officer and the staff of his office. Working closely with the Senior Corporate Leadership Team, this position will be responsible for planning, compiling, authoring, reviewing, interpreting, and distributing quality regulatory submissions to meet Health Authority (HA) commitments and corporate goals; maintaining compliance with corporate, divisional and HA policies/procedures and regulations; evaluating regulatory risks for various strategies and make recommendations to management; and influencing the adoption of identified regulatory strategies while remaining current on new developments.

The Vice President of Regulatory and Quality Systems will work with both internal and external personnel to provide technical support to assure the advancement of the R&D pipeline, transfer products from R&D to production, and to support ongoing production operations. The Vice President of Regulatory and Quality Systems will require knowledge of, and experience with, medical device requirements and enforcement practices to ensure the company remains in compliance at all times.

REPORTING RELATIONSHIPS:

• The Vice President, Regulatory & Quality Affairs will report directly to the President and Chief Executive Office.

• The Vice President, Regulatory & Quality Affairs will provide regular and timely feedback to the President/CEO and designated corporate management staff on a variety of topics including:

1. Status of the worldwide regulatory and quality programs
2. Recruiting/hiring status as approved and required
3. Vendor and contract agency evaluations
4. Organizational performance
5. Expense-Budget vs. Actual
6. Preclinical and clinical studies and operations
7. Recommendations for product enhancements based on regulatory/clinical acceptance

RESPONSIBILITIES:

• Develop regulatory strategies, with risk assessments and updates, that meet overall corporate and specific product and worldwide market introduction goals, and that are proactive and responsive to changes in Company plans and governmental requirements.
  
• Plan and conduct formal meetings and teleconferences with regulatory authorities to facilitate the review and approval of marketing applications with high-level management and worldwide regulatory authorities.
• Implement quality systems and strategies for specific products, projects and existing products and facilities to expedite and facilitate regulatory filing, review and approval, to protect continued marketing of existing products and to meet or exceed customer expectations.
• In collaboration with the Chief Technical Officer, the Intellectual Property Counsel and others, establish technical testing requirements at the developmental stage to determine candidate product?s feasibility, and develop the project plans to achieve developmental objectives and goals.
• Develop study protocols, ensure that preclinical and clinical investigations are conducted in accordance with applicable regulations, within the US and outside the US, and negotiate agreements with physicians to provide timely, cost effective and conclusive safety and efficacy data.
• Develop effective regulatory filings that result in product approvals that meet product and market introduction goals and result in the protection of continued marketing.
• Ensure that all appropriate registrations, certifications, dossier and technical file updates, listings, licenses and other regulatory documents are obtained and current to allow marketing and distribution of products in all intended worldwide markets.
• Develop and implement quality inspections for all appropriate manufacturing stages and steps to ensure that all products released for distribution meet or exceed established specifications and customer expectations.
• Develop critical quality indicators to monitor and identify potential problems and for continuous improvement.
• Review, approve, and provide guidance for products labeling and marketing advertising in all media formats to ensure compliance with applicable FDA, FTC and worldwide laws and regulations.
• Provide regulatory and quality support to project teams to ensure risk management and design controls are applied, and their timely and successful completion.
• Perform duties of the ?Management Representative? and represent the company before regulatory agencies, certification bodies.
• Conduct Management Reviews with top Management to report and discuss the adequacy and effectiveness of the company?s Quality system, and to identify any need for improvement.
• Maintain awareness of all regulatory approval and compliance requirements to 1) inform senior management of potential regulatory, compliance or quality risks and necessary corrective actions, and 2) ensure the promotion of awareness of current regulatory, quality and compliance requirements throughout the organization.
• Provide regulatory requirements training and facilitate the transfer of knowledge to company employees.               Form strong alliances with peers and externally with strategic partners for the purpose of completing departmental and company objectives.
• Develop the annual budget for Regulatory Affairs and Quality Assurance.
• Ensure all appropriate certifications, licenses, and registrations are obtained in order to design, evaluate, manufacture, and distribute products in all intended markets worldwide.
• Lead the review, analysis, and guidance of failure investigations and corrective actions referred to Regulatory Affairs.
• Perform other duties as assigned by Management