Director – Regulatory Affairs

A fast growing company is looking for a Director, Regulatory Affairs. In this role, the candidate will:

• Assumes a leadership role in preparing the corporation for pharmaceutical and device-oriented submissions and compliance audits.  
• Ensures compliance of company quality systems to regulatory requirements: including but not limited to Quality Systems Regulations (USA), ISO 13485, GMP and other country specific regulations where the company has commercial interests.
• Assists in performing audits and special investigations as required.
• Recommends strategies for fast track approvals of clinical trials and marketing applications and keeps abreast of regulatory procedures and changes.
• Develops and executes Departmental objectives for the improvement of corporate systems, including the development and implementation of policies, procedures and regulatory/quality company standards
• Prepares, manages and presents study and submission budgets, plans and project timelines.
• Prepares documents for regulatory submissions, internal audits, and inspections, including responsible for the coordination and preparation of materials required in submissions, license renewals, and annual registrations.
• Interacts with regulatory authorities and bodies, as required.
• Interacts effectively with team members and participates at project team meetings (PTM).

• University Degree in science or health related discipline;
• Minimum of seven-year experience in the pharmaceutical industry and a minimum of three years in the medical device industry;
• In-depth working knowledge of regulatory requirements and procedures for pharmaceutical products and medical devices;
• Very strong ability to manage multiple tasks with competing priorities in a demanding, fast-paced and entrepreneurial environment;
• Highly developed interpersonal skills with the ability to work equally well independently and in a team environment;
• Candidate also has led a multidisciplinary team in test protocol design, execution and analysis; developed and executed quality objectives for product development and manufacturing of single use medical devices as well as medical equipment;
• Proven track record in regulatory work demonstrated by significant accomplishments and/or approvals;
• Proven track record in the successful completion of quality certifications (ISO, GMP or QSR) and audits;
• Results-oriented professional with the ability to think strategically and creatively; 
• Dedicated self-starter with strong organizational skills and committed to the achievement of objectives;