Global Medical Device Regulatory Strategist

Cedent; Dallas (TX); On-site; USD 80,000 - 100,000; Full time

Job summary

A medical device consultancy is seeking a Regulatory Affairs Consultant in Dallas, TX. The role involves providing expert guidance on navigating complex regulatory landscapes and ensuring compliance with global medical device regulations. The ideal candidate has at least 3 years of experience in regulatory affairs, particularly with regulatory submissions and approvals. This full-time position offers a dynamic work environment and requires strong analytical and communication skills.

Qualifications

• Minimum of 3 years of experience in regulatory affairs within the medical device industry.
• Proven track record of successful regulatory submissions and approvals.
• In-depth knowledge of regulatory requirements for medical devices.

Responsibilities

• Develop and implement regulatory strategies for medical devices.
• Prepare and review regulatory submission documents.
• Conduct risk assessments to determine appropriate regulatory oversight.

Skills

Regulatory requirements knowledge

Excellent communication skills

Problem-solving abilities

Analytical skills

Education

Bachelor's degree in Life Sciences, Engineering, or a related field

Advanced degree (e.g., Master’s, PhD, Regulatory Affairs Certification)

Tools

Regulatory software tools

Job description

A medical device consultancy is seeking a Regulatory Affairs Consultant in Dallas, TX. The role involves providing expert guidance on navigating complex regulatory landscapes and ensuring compliance with global medical device regulations. The ideal candidate has at least 3 years of experience in regulatory affairs, particularly with regulatory submissions and approvals. This full-time position offers a dynamic work environment and requires strong analytical and communication skills.