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Senior Manager - Regulatory Affairs

RENAUDEXEC

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At RENAUDEXEC, we're committed to knowing who you are, what you're searching for and supporting your future aspirations. We work to achieve the best match between you and one of the many life sciences organizations we serve.

We pride ourselves on:

DISCRETION

Our relationship with you is strictly confidential. Your information shall be conveyed only with your permission.

ATTENTIVE LISTENING

We have to ask you questions, but first and foremost, we have to listen attentively to get to know who you are and what you seek.

RESPECT

Respect is of paramount importance to us; we intend to treat you with respect as well as to earn your respect.

FOLLOW-UP

We know that job seeking can be a time where anxiety may increase. This is why we commit ourselves to do frequent and serious
follow-ups.

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Director - Regulatory Affairs
 
Job : 091330 - Director - Regulatory Affairs
Field : Medical , Pharmaceutical
Region : Washington, DC
Job description :

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 skills and qualifications :

  • 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;

 

   
If you are interested in this job, please contact Chantal Melançon by email at chantal@renaudexec.com and state the job title and offer number : 091330
 

We thank you for your interest, however, only those selected for an interview will be contacted.

 

Our commitment:

Confidentiality, follow-up, listening and respect


 
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