Director – Regulatory Affairs

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Washington, DC
Job Type
Permanent position
Job number


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).

Specific knowledge

  • 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;


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