Global Principal Quality & Regulatory Leader (IVD)

BioTalent; Portland (ME); On-site; USD 100,000 - 130,000; Full time

Job summary

A medical device company in Portland, ME, is seeking a Principal Quality & Regulatory Specialist to lead global regulatory strategy and quality system compliance. You will manage regulatory submissions, strengthen the Quality Management System, and mentor junior staff. The ideal candidate has proven experience in regulatory affairs, particularly in the IVD or medical device industry, and possesses strong communication and leadership skills.

Qualifications

• Proven experience in regulatory affairs within the IVD or medical device industry.
• Successful track record with global submissions including FDA and EU IVDR.
• Deep knowledge of quality systems and ISO 13485.

Responsibilities

• Serve as the in-house expert on global IVD regulatory submissions.
• Develop and manage regulatory strategies to ensure successful registrations.
• Oversee and strengthen the Quality Management System in compliance with ISO standards.

Skills

Regulatory affairs expertise

Quality Management Systems

Communication skills

Leadership skills

Education

Advanced degree or RAC certification

Job description

A medical device company in Portland, ME, is seeking a Principal Quality & Regulatory Specialist to lead global regulatory strategy and quality system compliance. You will manage regulatory submissions, strengthen the Quality Management System, and mentor junior staff. The ideal candidate has proven experience in regulatory affairs, particularly in the IVD or medical device industry, and possesses strong communication and leadership skills.