Sr. Regulatory Affairs Specialist - Hudson, NH

Sr. Regulatory Affairs Specialist

Our client has is a leading manufacturer with vast expertise in
developing technologies for the treatment of cardiovascular disease
has brought breakthrough technologies to those unmet clinical needs in
several diversified healthcare markets. They are currently looking to
fill a full-time permanent position as a Senior Regulatory Affairs
Specialist.

Responsibilities:
* Prepares Regulatory strategy/plans and requirements.
* Prepares worldwide regulatory submissions. PMA, 510K AND IDE's
* Support engineering changes through RA/QA practices by documenting
the changes in compliance with the Quality System Regulations, the
Medical Device Directives, CMDR.
* Interface between Regulatory Agencies such as the FDA and the
European Notified Body
* Responsible for the FDA/ISO/MDD/CMDR compliance documentation.

Qualifications:
* BA in related field and a minimum of 5 yrs experience.
* GLP/GMP environment.
* FDA & International regulatory requirements and systems.
* Strong negotiating skills as well as effective project management
skills.
* Strong verbal, written and communications skills

Location: Hudson, New Hampshire, USA

If you choose to join the exciting team at this renowned company, you
will be rewarded with a competitive salary and full benefits.

Apply today to recruiting.RemoveThis@fuzehr.com - www.fuzehr.com

Thank you for your application, however only chosen candidates will be
contacted.

** If you are not currently in the market for a new job, but know
someone who could benefit from this opportunity, please don't hesitate
to forward this information, thank you.