Global Regulatory Submissions Lead, Medical Devices

Integrated Resources Inc.; Wayne (PA); On-site; USD 70,000 - 90,000; Full time

Job summary

A premier staffing firm is looking for a Regulatory Affairs professional to coordinate global submissions for in vitro diagnostic devices. The ideal candidate will have a scientific degree, relevant industry experience, and strong communication, organizational, and project management skills. This role requires an understanding of US and international medical device regulations.

Qualifications

• At least 2 years of medical device or related industry experience.
• Knowledge of US, EU and international medical device regulations.
• Ability to work independently and collaboratively.

Responsibilities

• Coordination of global regulatory submissions for in vitro diagnostic devices.
• Planning and submitting product registration applications.
• Researching and consolidating global regulatory requirements.

Skills

Verbal communication

Written communication

Organizational skills

Project management

Interpersonal skills

Negotiation skills

Problem solving

Attention to detail

Education

Degree in a scientific or technical field

Tools

MS Office

Electronic document management systems

Job description

A premier staffing firm is looking for a Regulatory Affairs professional to coordinate global submissions for in vitro diagnostic devices. The ideal candidate will have a scientific degree, relevant industry experience, and strong communication, organizational, and project management skills. This role requires an understanding of US and international medical device regulations.