Regulatory Affairs Specialist

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 Few Words About Us - Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

Job Description

Role profile: This role will be responsible for co-ordination of global regulatory submissions for in vitro diagnostic devices.

Responsibilities will include:

• Partnering with global regulatory contacts to understand requirements for product registrations for new and modified products

• Partnering with global regulatory contacts to plan, develop and submit product registration applications for new and modified products

• Obtaining and maintaining documents required for global registrations such as Certificates to Foreign Government and Certificates of Free Sale.

• Assisting with tracking of global registration status of all products.

• Researching and consolidating global regulatory requirements to enable future development of global regulatory strategies.

• Assisting in the development of best practices for Regulatory Affairs processes

Qualifications

• Degree qualified, preferably in a scientific or technical field

• At least 2 years of medical device, diagnostic or related industry experience.

• Knowledge and understanding of US, EU and international medical device regulations.

• Excellent verbal and written communication skills

• Strong organizational and project management skills.

• Strong interpersonal, negotiation and problem solving skills; detail oriented

• Ability to work independently and collaboratively with minimal supervision

• Working knowledge of MS Office programs (Word, Excel, PowerPoint, Outlook) and electronic document management systems

Additional Information

Warm Regards,

NIMISHA DROACH

Integrated Resources, Inc

IT REHAB CLINICAL NURSING

Inc. 5000 - 2007, 2008, 2009, 2010, 2011, 2012 & 2013 (7th Year)