Global Regulatory Affairs Specialist – Medical Devices

Ormco; Brea (CA); On-site; USD 86,000 - 105,000; Full time

Benefits offered by this job

Annual bonus

Medical/dental/vision benefits

401K match

Job summary

Ormco is seeking a Regulatory Affairs Specialist to drive global product registrations, maintain regulatory filings, and align with EU MDR requirements. You will collaborate with cross-functional teams and coordinate with global registration partners to support a broad product portfolio.

The role requires 2+ years in regulatory affairs for medical devices or regulated industries, with strong CER/SSCP/PSUR experience, and an on-site work arrangement of at least four days per week.

Qualifications

• Bachelor's Degree required.
• 2+ years in Regulatory Affairs for medical devices or regulated industry; Master’s with 1+ year considered.
• Strong knowledge of EU MDR including CER/SSCP/PMS/PSUR.

Responsibilities

• Assemble and maintain CE technical files per regulatory requirements.
• Prepare and review CER/SSCP/PSUR/PMS reports.
• Monitor regulatory changes and assess impact on operations.
• Develop SOPs and technical documentation for compliance.
• Collaborate with global registration teams for diverse product registrations.
• Coordinate regulatory strategies and ensure timely registrations.
• Submit regulatory filings for global markets.
• Liaise with distributors, consultants, and partners for regulatory needs.
• Review changes to determine regulatory reporting obligations.
• Provide guidance on complex compliance landscapes.
• Stay informed on regulatory developments and participate in special projects.

Skills

EU MDR knowledge

CER/SSCP/PSUR

Regulatory strategy

Cross-functional

Detail-oriented

Time management

Regulatory reporting

Project management

Communication skills

Multinational submissions

Education

Bachelor's Degree

Tools

Microsoft Office

Job description

Ormco is seeking a Regulatory Affairs Specialist to drive global product registrations, maintain regulatory filings, and align with EU MDR requirements. You will collaborate with cross-functional teams and coordinate with global registration partners to support a broad product portfolio.

The role requires 2+ years in regulatory affairs for medical devices or regulated industries, with strong CER/SSCP/PSUR experience, and an on-site work arrangement of at least four days per week.