Job Description
Our client, a leading medical device company, is currently recruiting a Director of Regulatory Affairs who will infuse the Regulatory Affairs Team with their talent, energy and leadership skills. This is an exceptional opportunity to join a corporate culture that is known for its innovative and growth-oriented vision. Responsibilities include:
1) Communicate regulatory strategy at the corporate level
2) Manage and execute regulatory strategies for earliest possible approvals of the company’s regulatory applications at all stages of development
3) Provide guidance on interpretation and application of global medical device regulations
4) Ensure the compliance with global regulatory requirements
5) Develop and implement strategies for timely submission and approval of pre-clinical submissions, applications for clinical trials and marketing applications
6) Interact with and manage regulatory agency inspections
7) Provide support during partner and customer audits
8) Ensure the timely preparation of organized and scientifically valid applications.
9) Provide expertise in translating regulatory requirements into practical and workable plans
10) Select, develop and evaluate, counsels’ personnel to ensure the efficient operation of the function
11) Prepare, communicate and evaluate team goals and objectives for continual improvement of the efficiency and effectiveness of the Regulatory Department
12) Develop positive and proactive approaches to regulatory compliance
Critical Requirements
1) A university degree is required. Although all candidates are welcome and encouraged to apply, preference will be given to those with degrees in a relevant field
2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)
3) Recent experience in the medical device industry is strongly preferred
4) Preference will be given to candidates with recent experience in regulatory affairs management
For the right leader, this is a wonderfully rewarding role with tremendous growth prospects. If you are qualified and think you're a strong fit for this role, please apply ASAP. We thank all applicants, but only candidates who meet our client's criteria will be contacted.
Compensation and Other Details
Base Salary: Highly competitive package, commensurate with experience