Lead Regulatory Affairs Specialist

Globus Medical; King of Prussia (Montgomery County); On-site; USD 80,000 - 120,000; Full time

Job summary

An established industry player is seeking a Lead Regulatory Affairs Specialist to drive compliance and regulatory strategies for innovative medical devices. In this pivotal role, you will oversee regulatory submissions, coordinate product registrations, and ensure adherence to regulatory standards. Your expertise will guide interactions with regulatory agencies and influence clinical trial approvals. Join a passionate team dedicated to innovation and customer focus, where your contributions will shape the future of healthcare solutions. This is an exciting opportunity for seasoned professionals eager to make a significant impact in the medical device sector.

Qualifications

• 8+ years of experience in regulatory affairs with a strong understanding of compliance.
• Ability to evaluate regulatory impacts of product changes.

Responsibilities

• Develop regulatory strategies and ensure compliance documentation.
• Collaborate with departments to review regulatory decisions and plans.

Skills

Regulatory Compliance

Project Planning

Multi-tasking

Regulatory Strategy Development

Education

Bachelor's Degree in a related field

12+ years in the medical device industry

Job description

Join to apply for the Lead Regulatory Affairs Specialist role at Globus Medical.

This position involves reviewing document packages for regulatory submissions, ensuring compliance, coordinating product registration activities, and leading interactions with regulatory agencies. The role requires staying updated with regulatory procedures, driving strategies for clinical trial approvals, and overseeing labeling, manufacturing, and marketing compliance.

Key Responsibilities include:

1. Developing regulatory strategies for new products and ensuring compliance documentation.
2. Interfacing with regulatory agencies and certifying bodies for inspections and submissions.
3. Collaborating with departments to review plans, procedures, and regulatory decisions.
4. Evaluating the regulatory impact of product or process changes.
5. Reviewing promotional materials for compliance.
6. Maintaining regulatory records.

Qualifications:

• Understanding of regulatory requirements throughout the product lifecycle.
• Knowledge of regulatory terminology and submission types.
• Ability to evaluate regulatory impacts of changes.
• Strong multi-tasking and project planning skills.
• Minimum of 8 years of related experience with a Bachelor's degree, or equivalent experience.
• 12+ years of experience in the medical device industry.

Physical Demands: Sitting, balancing, stooping, lifting up to 25 pounds, and specific vision abilities.

Our Values: Passionate About Innovation, Customer Focused, Teamwork, Driven.

Equal Employment Opportunity: We value diversity and are committed to an inclusive environment.

Note: Duties may change; this description is not exhaustive.