Regulatory Affairs Specialist Leader
The position involves developing strategic plans and submissions for complex regulatory projects and issues related to documents, product development planning, and regulatory agency interaction.
Key responsibilities include:
* Managing global regulatory compliance
* Developing technical documentation
* Assessing and mitigating regulatory risks
* Providing support for R&D projects
* Applying technical solutions to problem-solving and quality improvement initiatives
* Reviewing and assessing change control activities
* Maintaining Regulatory procedures to ensure compliance
Required skills and experience include:
* Engineering/Science qualification with 5 years of working in a medical device environment
* Minimum of 3 year's experience in R&D/QA/RA
* Excellent technical writing experience within a medical device environment
* Fluent English language skills
* Ability to work well under deadlines and pressure
* Problem solving skills for developing creative solutions
This is an exciting opportunity to join our team as a highly skilled Regulatory Affairs Specialist. As a key member of our organization, you will be responsible for leading the development of strategic regulatory plans and ensuring compliance with regulatory requirements.
We are looking for a talented individual who can bring their expertise in regulatory affairs to our team. If you have a passion for regulatory compliance and excellent communication skills, we encourage you to apply for this role.