Senior Regulatory Specialist
We are seeking an experienced regulatory professional with a strong track record in quality assurance and regulatory affairs to join our team.
* Support and advise senior management on regulatory activities and strategies.
* Develop and lead regulatory submissions, responding to questions from health authorities.
* Collaborate with the development team to ensure data quality and submission goals are met.
* Develop and manage product design documentation, ensuring compliance with regulations.
* Ensure compliance with health authorities and emerging legislation.
The ideal candidate has a degree in a scientific or engineering discipline, at least 7 years of experience in Quality Assurance or Regulatory Affairs, and expertise in preparing regulatory submissions.
Key Responsibilities:
Regulatory Compliance:
Maintain knowledge of relevant laws, regulations, and guidelines.
Submission Preparation:
Prepare and submit high-quality regulatory documents.
Collaboration:
Work closely with cross-functional teams to achieve project goals.
Communication:
Effectively communicate with stakeholders, including health authorities.
Qualifications:
Educational Background:
Bachelor's or Master's degree in a scientific or engineering discipline.
Experience:
At least 7 years of experience in Quality Assurance or Regulatory Affairs.
Skills:
Strong understanding of regulatory requirements, excellent communication skills, and ability to work in a fast-paced environment.