Regulatory Affairs Lead – Medical Devices (Global)

Orchid Orthopedic Solutions LLC; Warsaw (IN); On-site; USD 90,000 - 120,000; Full time

Job summary

Orchid Orthopedic Solutions LLC is seeking a Sr. Regulatory Affairs Specialist to drive regulatory submissions, annual reports, registrations and listings.

You will guide stakeholders on regulations to ensure domestic and international compliance, and coach teams on best practices while conducting audits. Responsibilities include maintaining regulatory listings, participating in ISO audits, and collaborating with multiple departments to resolve compliance issues in a fast-paced manufacturing

Qualifications

• Working knowledge of government and international medical device regulations (FDA, MDD, CMDCAS, PAL, ISO).
• Minimum four years of experience in a quality and regulatory related field.

Responsibilities

• Field complaint investigations and reporting.
• Perform regulatory reviews of product files for release.
• Collaborate with departments to address compliance issues.
• Provide training on compliance matters to staff.
• Act as liaison between the company and regulatory bodies.
• Stay updated with changes in regulatory landscape and industry standards.
• Maintain FDA MDL listings/submissions for products.
• Participate in ISO audits and Technical File Reviews.
• Annual review of all products (PMS).
• Design reviews participation and regulatory documentation.

Skills

Regulatory knowledge

Audit experience

Regulatory submissions

Education

Bachelor of Science Degree

Tools

MS Word

Excel

PowerPoint

Job description

Orchid Orthopedic Solutions LLC is seeking a Sr. Regulatory Affairs Specialist to drive regulatory submissions, annual reports, registrations and listings.

You will guide stakeholders on regulations to ensure domestic and international compliance, and coach teams on best practices while conducting audits. Responsibilities include maintaining regulatory listings, participating in ISO audits, and collaborating with multiple departments to resolve compliance issues in a fast-paced manufacturing