Regulatory Affairs Specialist

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. 

• As required, performing labelling reviews/approvals. 

• 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

 • 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

Warm Regards,

NIMISHA DROACH

Integrated Resources, Inc

IT REHAB CLINICAL NURSING

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

Certified MBE I GSA - Schedule 66 I GSA - Schedule 621I I GSA - Schedule 70

(Direct) 732-429-1630

Tel: (732) 549 2030 x 226

Fax: (732) 549 5549