Ultrasound Regulatory Specialist

CITY: Wauwatosa STATE: Wisconsin COUNTRY: USA Essential Functions (Responsibilities):
* Lead development and maintenance of product approval/clearance/licensing documentation and notifications as required by regulatory agencies and specific countries.
* Work closely with other functional areas (e.g. Marketing, Engineering, Manufacturing, Service) to ensure process and product compliance to applicable regulations in the areas of Design, Service and Manufacturing.
* Ensure Regulatory reporting/documentation is completed and updated as required. Includes but is not limited to: Facility and Product Registration, Licensing and Market Authorizations.
* Develop effective regulatory strategies for assigned projects which meet business goals
* Lead and support continuous improvement activities assigned, which may include such areas as: Standards compliance, Risk management, Corrections and metrics development/implementation.
* Provide senior management with key data from RA to help drive decisions
* Provide leadership to the RA approvals team to ensure team objectives are met
* Liaise with internal personnel and external regulatory bodies to ensure appropriate input into regulatory strategy and ensure approval within milestone goals for submissions of assigned projects
* Identify, assess and manage regulatory risk proactively.

Qualifications/Requirements:
* Bachelor's Degree in Engineering or technical field, and 4+ years experience in a medical device or pharmaceutical industry; or a minimum 8+ years of Quality Assurance/Regulatory Affairs experience in medical device or pharmaceutical industry, including:
-Knowledge and experience applying drug or device laws as well as regulations by external bodies
-Applying Corrective and Preventative Action to processes
-Handling of complaint processes
-Handling adverse event and recall issues
-Completing Statistical and root cause analysis
* Awareness of local and international regulatory agencies
* Knowledge of a New Product Introduction process
* Knowledge of Quality Management Systems
* Prior experience using spreadsheet and presentation software
* Working knowledge of English language (oral and written)
* Must be willing to take a drug test
* Must be willing to submit to a background investigation, including for example, verification of your past employment, criminal history, and educational background
* Must be legally authorized to work in the United States
* Must be willing to work out of an office located in Milwaukee, WI
* Must be willing to travel 20% of time

Desired:
* Experience interfacing with external regulatory agencies (e.g. FDA)
* Ability to set priorities for the team
* Strong knowledge of assigned business operations and knowledge of product specific safety standards and work groups
* Ability to work across cultures/poles/sites
* Excellent written and verbal communication skills with the ability to communicate business issues in an easy to understand manner
* Regulatory Affairs Certification (RAPS)
* Accepting constructive criticism and dealing calmly and effectively with high-stress situations. This includes continuing to persevere and remaining calm in challenging or frustrating circumstances.
* Dependability: Being reliable, responsible, dedicated, committed and fulfilling obligations
* Adaptable/Flexible: Being open to change (positive or negative) in response to new information, different or unexpected circumstances, and/or to work in ambiguous situations
* Integrity: Accepting and adhering to high ethical, moral, and personal values in decisions, communications, actions, and when dealing with others

General:
In this role, the Regulatory Affairs Specialist will provide guidance to Ultrasound Regulatory teams to ensure GEHC establishes best practice standards in the development of new products and post market support of products.


We offer a competitive salary, outstanding benefits package and the professional advantages of an environment that supports your development and recognizes your achievements. We are an Equal Opportunity Employer.