An innovative med device company is looking to bring on a Director of Regulatory Affairs in an exciting and globally focused position. This is a high-priority position for the regulatory team and allows someone to join a company who is experiencing rapid growth.

Global Director of Regulatory Affairs

An innovative diagnostic company is looking to bring on a Director of Regulatory Affairs in an exciting and globally focused position. This is a high-priority position for the regulatory team and allows someone to join a company who is experiencing rapid growth.

Responsibilities:

• Lead the submission of documents to FDA, and other global regulatory agencies
• Develop and maintain Technical Files for CE marking.
• Identify and develop new regulatory policies, processes and SOPs.
• Assures medical device reports (MDR) are reported to regulatory agencies and internal stakeholders.
• Assess the regulatory impact of post-market changes to labeling, design, materials, or manufacturing process.
• Represent regulatory affairs on product development teams.

Qualifications:

• Minimum 7-10 years in regulatory affairs within the medical device industry
• Experience in OUS regulatory submissions
• Minimum Bachelor’s degree in a technical discipline required; Master’s Degree in a technical discipline preferred.
• Demonstrated ability to interpret and stay current with FDA, EU and other regulatory agency regulations and guidelines.
• Team player
• Strong leader with a passion for the industry

Qualifications:

• Minimum 7-10 years in regulatory affairs within the medical device industry
• Experience in OUS regulatory submissions
• Minimum Bachelor’s degree in a technical discipline required; Master’s Degree in a technical discipline preferred.
• Demonstrated ability to interpret and stay current with FDA, EU and other regulatory agency regulations and guidelines.
• Team player
• Strong leader with a passion for the industry

Compensation: 160,000 - 198,000 plus 25% bonus, several weeks of vacation, great benefits, full relo

All your information will be kept confidential according to EEO guidelines.

For internal use only: CO_ID:695