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Senior RAQA Consultant
3 months ago
About Our Client
Our client is a fast growing medical devices consultancy, specialising in regulatory compliance, patents, clinical investigation and market entry.
Job Description
- Ensure compliance with all relevant regulatory standards and guidelines within the healthcare industry.
- Develop and implement Regulatory Affairs and Quality Assurance strategies.
- Provide guidance and support to Clients.
- Communicate effectively with regulatory authorities.
- Prepare and submit regulatory documents to appropriate bodies.
- Oversee internal audits and inspections to ensure compliance.
- Collaborate with cross-functional teams to support product development.
- Stay up to date with changes in regulatory legislation and guidelines within the healthcare industry.
The Successful Applicant
A successful Senior RAQA Consultant should have:
- A degree in Life Sciences, Pharmacy, or a related field.
- Extensive knowledge of Regulatory Affairs and Quality Assurance within the healthcare industry (Experience in SaMD is essential)
- Excellent communication and leadership skills.
- Strong ability to work collaboratively in a global team environment.
- High attention to detail and organisational skills.
- Experience in preparing and submitting regulatory submissions.
What's on Offer
- A competitive salary
- Equity share opportunities
- Remote working