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Global Regulatory Director

3 months ago

Prairie du Sac, Wisconsin, United States Mueller Sports Medicine Full time
Job Details

Job Location
Corporate Headquarters - Prairie du Sac, WI

Position Type
Full Time

Education Level
Bachelor Degree (4 years)

Travel Percentage
Negligible

Job Shift
M-F; 8 am - 4:30 pm

Job Category
QA - Quality Control

Description

POSITION OVERVIEW: Responsible for Material Quality Control, Regulatory Compliance, and the Quality Management System at Mueller Sports Medicine, Inc. (MSM).

POSITION FUNCTIONS*

Percentage

Position Functions

40%

Leadership & Management
  • Lead all aspects of the quality and regulatory department.
  • Manages with excellence, utilizes resources efficiently, and develops talent.
  • Direct strategy and tactics to achieve objectives.
  • Produce and monitor an annual budget.
  • Serve as management representative for the Quality Management System (QMS).
  • Cross train and collaborate between the Quality and Regulatory function.
  • Provide input and feedback regarding risk analysis activities including remaining active in the Risk Management Team.
60 %

Quality & Regulatory
  • Facilitate and provide coverage for internal and external audits and inspections from any agency or customer. Including Regulatory Compliance and Quality Inspections.
  • Perform QMS maintenance, continuous improvement, corrective/preventative action (CAPA) and training procedures.
  • Submit Regulatory Manager and Quality manager report to the DGQ.
  • Manage domestic and international sub-contractor quality control systems including 3rd party quality services (MSM or Customer).
  • Ensure Quality Department and Regulatory Affairs related material activities are within guidelines of the Food and Drug Administration (FDA) including Quality System Regulation (21 CFR 820), current Good Manufacturing Practices (21 CFR 210), European Union (EU) Medical Devices Directive (MDD)/Medical Device Reporting (MDR), Environmental Protection Agency (EPA) and Occupational Safety & Health Agency (OSHA).
  • Lead/manage internal audit process including scheduling, training, and determining effectiveness.
  • Lead/manage FDA (food, drug and medical), International Organization for Standardization (ISO) 13485, EPA and other external audit events (State, Federal & Local).
  • Work with Purchasing and Research & Engineering (R&E) in review and sign-off of product drawings and specifications.
  • Provide support to Purchasing/Sourcing in reviewing product related to sourcing projects, as well as vendor quality performance & tracking program.
  • Work with Human Resource (HR) to ensure new employees are trained in quality system procedures and regulatory guidelines.
NA

Other duties as assigned to meet the needs of the organization.

*Position Functions for this position consist of all items listed under any category that make up 5% or more of the position duties. This position description is subject to change without notice.

Qualifications

MINIMUM QUALIFICATIONS

Bachelor's degree in quality assurance, engineering, life science or other related field or an equivalent combination of education and experience sufficient to perform the position functions of the job.

Five or more years of quality, regulatory, or other related experience.

Three or more years of progressive leadership and management experience.

Ability to understand and comply with Mueller Safety Systems and current regulatory requirements.

PREFERRED QUALIFICATIONS

ISO 13485 lead auditor certification.

American Society of Quality (ASQ) certification, Regulatory Affairs Professional Society (RAPS) certification and process audit experience.

REQUIRED SKILLS

Exercises judgment within broadly defined practices and policies.

Makes sound decisions based on analysis, discussion, experience and judgment.

Demonstrated team player with active participation in meetings.

Selects, evaluates, and engages team members.

Strong planning and project management skills.

Strong ability to transition efficiently from working independently to working collaboratively.

Anticipates emerging and future trends accurately based on broad knowledge and perspective.

Willingness to "roll up your sleeves" to help find new opportunities, be diligent in holding people accountable, and having passion to WIN.

Excellent written and verbal communication skills, with ability to communicate at all levels of the organization including with the board.

Communicate a vision and providing motivation and direction to team members.

Develops and maintains interpersonal relationships.

Strong organizational and problem-solving skills, attention to detail, and the ability to balance multiple priorities.

Advanced use of Microsoft products, including Word, Outlook and Excel, and related industry applications.

Creates focus and eliminates roadblocks for team members.

Develops and manages a budget.

Valid driver's license.

Responsible to appropriately protect the confidentiality, security, and integrity of the organization's systems and data as well as client data.

PHYSICAL REQUIREMENTS: While performing the duties of this job, the team member is required to have ordinary ambulatory skills; ability to stand or sit, bend or stoop, and manipulate (lift, carry, move) light weights of up to 20 pounds. Requires good hand-eye coordination, arm, hand and finger dexterity, including ability to grasp, and visual acuity to use a keyboard, operate office equipment and read. The team member frequently is required to sit, reach with hands and arms, talk and hear. Position requires frequent typing. Position requires occasional domestic and international business travel, including operation of a motor vehicle.