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:


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.