Regulatory Affairs Executive

confidential; Riyadh; On-site; SAR 200,000 - 300,000; Full time

Job summary

A leading healthcare firm in Saudi Arabia is seeking a Regulatory Affairs Specialist to ensure compliance with regulations for medical devices. This role involves preparing regulatory submissions, managing product registrations, and collaborating with teams to align product development with regulatory standards. The ideal candidate will have strong analytical skills and experience in the healthcare industry. A commitment to regulatory compliance and safety is crucial.

Qualifications

• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal abilities.
• Detail-oriented with a high level of accuracy.
• Ability to work independently and manage multiple projects.
• Proficient in regulatory documentation and submission processes.
• Experience in the medical device or healthcare industry.
• Knowledge of quality management systems and standards.
• Ability to adapt to changing regulations and industry trends.
• Strong organizational skills and time management.
• Commitment to continuous professional development in regulatory affairs.

Responsibilities

• Prepare and submit regulatory documents for compliance.
• Manage product registrations and maintain records.
• Conduct reviews of product labeling for compliance.
• Collaborate with teams to align product development with regulations.
• Monitor changes in regulations and assess their impact.
• Provide guidance on regulatory requirements.
• Prepare for regulatory inspections and audits.
• Develop relationships with regulatory agencies.
• Assist in responses to regulatory inquiries.
• Support regulatory strategies for new products and expansions.

Skills

Knowledge of regulatory requirements for medical devices

Understanding of quality management systems (QMS) ISO 13485

Proficiency in regulatory submission software and tools

Excellent written and verbal communication skills

Ability to interpret complex regulations and guidelines

Strong project management skills

Familiarity with clinical trial processes

Ability to work collaboratively in a team environment

Job description

The Regulatory Affairs Specialist plays a crucial role in ensuring that medical and healthcare equipment complies with all regulations and standards set by governmental and international bodies. This position involves a deep understanding of the regulatory landscape and the ability to navigate complex compliance requirements. The specialist will be responsible for preparing and submitting regulatory documents, managing product registrations, and ensuring that all products meet safety and efficacy standards before they reach the market. This role is essential for maintaining the company's reputation and ensuring the safety of healthcare products.

Responsibilities:

1. Prepare and submit regulatory documents to ensure compliance with local and international regulations.
2. Manage product registrations and maintain up-to-date records of regulatory submissions.
3. Conduct thorough reviews of product labeling and promotional materials for compliance.
4. Collaborate with cross-functional teams to ensure that product development aligns with regulatory requirements.
5. Monitor changes in regulations and assess their impact on the company's products.
6. Provide guidance and training to internal teams on regulatory requirements and best practices.
7. Prepare for and participate in regulatory inspections and audits.
8. Develop and maintain relationships with regulatory agencies.
9. Assist in the preparation of responses to regulatory inquiries and issues.
10. Support the development of regulatory strategies for new products and market expansions.

Preferred Candidate:

1. Strong analytical and problem-solving skills.
2. Excellent communication and interpersonal abilities.
3. Detail-oriented with a high level of accuracy.
4. Ability to work independently and manage multiple projects simultaneously.
5. Proficient in regulatory documentation and submission processes.
6. Experience in the medical device or healthcare industry.
7. Knowledge of quality management systems and standards.
8. Ability to adapt to changing regulations and industry trends.
9. Strong organizational skills and time management.
10. Commitment to continuous professional development in regulatory affairs.

Skills

• In-depth knowledge of regulatory requirements for medical devices.
• Strong understanding of quality management systems (QMS) ISO 13485.
• Proficient in regulatory submission software and tools.
• Excellent written and verbal communication skills.
• Ability to interpret complex regulations and guidelines.
• Strong project management skills.
• Familiarity with clinical trial processes and documentation.
• Ability to work collaboratively in a team environment.