Regulatory Affairs Professional
We are seeking a highly skilled Regulatory Affairs Professional to join our team.
Job Description
The successful candidate will be responsible for executing regulatory activities and developing regulatory strategies to support the approval of medical devices.
Required Skills and Qualifications
* Bachelor's or Master's degree in a scientific or engineering discipline
* At least 7 years' experience in Quality Assurance or Regulatory Affairs for medical device companies
* Strong experience preparing and reviewing regulatory submissions to achieve timely approval
* Collaborative team player with solid knowledge of the medical device design and development process
* Excellent written, interpersonal communication and presentation skills
Key Responsibilities
1. Support and advise the VP Quality and Regulatory Affairs by executing regulatory activities and developing regulatory strategies
2. Develop regulatory submissions to ensure timely product clearance/approval and lead preparation, review and submission of high-quality responses to questions from regulatory agencies
3. Collaborate with the development team to ensure that the data is created using best scientific principles and that submission goals are met
4. Develop and manage product design and technical documentation in compliance with relevant regulations and standards
Benefits
This role offers a challenging and rewarding opportunity for an experienced Regulatory Affairs professional to make a meaningful contribution to our organization.
Others
If you are a motivated and detail-oriented individual with a passion for regulatory affairs, we encourage you to apply for this exciting opportunity.