Careers

Inspire and Commit to Each Other
Our personal integrity, trust of our colleagues, and dedication to our work creates
an environment of respect and excellence throughout Ameda.

This Ameda Core Value leads to a team-oriented culture where all are challenged to think beyond the obvious. If you have a desire to learn, grow and innovate, you can find purpose and satisfaction with us. At Ameda, you can make a contribution to an industry dedicated to improving the lives of mothers and babies.

There is no typical day at Ameda. Our market and our customers are always changing. This results in a highly stimulating atmosphere, where each employee can flourish based on his or her area of expertise.

Ameda is committed to creating opportunities for qualified, enthusiastic employees who want to broaden their skills. Our growth makes it possible to offer a spectrum of development options. We are interested in learning more about you. Resumes can be sent to Recruiting@ameda.com.

EEO/AA Employer

Current Opportunities

REGULATORY AFFAIRS SPECIALIST

Job Title:  Regulatory Affairs Specialist

Location – Buffalo Grove, IL

We are seeking an experienced regulatory affairs specialist to participate in and guide teams involved in the production, marketing, and distribution of Class I and II electromechanical devices and disposables to verify that all functions are operating according to regulations. The Regulatory Specialist must keep abreast of legislative developments in the countries or regions in which products are distributed, and advise and strategize with management, keeping them informed of the implications of regulatory developments and advising on methods to execute plans as needed. 

Responsibilities include: 

  • Monitor applicable regulatory requirements; assure compliance with internal procedures and external standards
  • Compile and maintain 510(k), Technical File and other regulatory files, in a format consistent with requirements.Complete memos to file assessing changes.
  • Develop regulatory project plans, and align with global, regional and local marketing strategies.
  • Prepare, review, and approve labelling and SOP’s
  • Complete product and facility registrations, license extensions and amendments, renewals according to agreed timeline, and ensure approvals in a timely manner for regions in which Ameda distributes.
  • Maintenance of regulatory databases
  • Provide front and back room assistance for audits.
  • Provide support for responding to audits.
  • Maintain Health Canada regulatory licenses.
  • Maintain Certificates of Conformance for the EU.
  • Providing regulatory advice and support for new product development.

Experience

  • Min 5-8 years regulatory experience in medical device industry with products marketed in the US, EU, and Canada.
  • BS degree in a technical discipline.
  • Experience filing 510K and other submission packages.
  • Proficient in 21 CFR 820 and the Medical Device Directive, and Canadian Medical Device Regulations.
  • Working knowledge of FDA and international regulations.
  • Working knowledge of quality management systems.
  • Experience dealing with notified bodies.
  • Working knowledge of 13485 and CE mark requirements.
  • Working knowledge of MDR Reporting.
  • Experience conducting internal audits and writing audit responses.
Essential Skills
  • Sound basis of Regulatory and scientific knowledge
  • Attention to detail and commitment to
  • Ability to manage complex projects and timelines in a matrix team environment
  • Written and verbal communication and presentation skills
  • Ability to independently identify compliance risks and escalate when necessary
  • Thorough knowledge of applicable procedures, specifications, regulations and standards.
  • Organized in self, work and environment
  • Able to work in a matrix and cross-cultural environment
  • PC skills including Word, Excel, and interest and ability to learn other programs as required

 Competencies

  • Excellent interpersonal skills.
  • Proficient in technical writing and oral communication.
  • Experience researching regulatory requirements.
  • Ability to plan, execute, and complete projects in timeframes allotted.
  • Ability to work independently.

 Required Behavioral Competencies

  • Quality Orientation - Accomplishes tasks by considering all areas involved, no matter how small; showing concern for all aspects of the job; accurately checks processes and tasks; is watchful over a period of time.
  • Builds Strategic Working Relationships - Develops and uses collaborative relationships to facilitate the accomplishment of work goals.
  • Facilitates Change - Encourages others to seek opportunities for different and innovative approaches to addressing problems and opportunities; facilitating the implementation and acceptance of change within the workplace.
  • Manages Work - Effectively manages one’s time and resources to ensure that work is completed efficiently.
  • Decision Making – Identifies and understands issues, problems, and opportunities; compares data from different sources to draw conclusions; use effective approaches for choosing a course of action or developing appropriate solutions; take action that is consistent with available facts, constraints, and probable consequences.
  • Initiates Action – Takes prompt action to accomplish objectives; takes action to achieve goals beyond what is required; is proactive.
  • Contributes to Team Success - Actively participates as a member of a team to move the team toward the completion of goals.

 

SUPPLY CHAIN PLANNER

We are seeking an experienced Supply Chain Planner responsible for the Sales and Operations Planning across Ameda’s Global supply chain.  This position is responsible for managing the execution of our contract manufacturing partners to produce product supporting our sales plan.   The goal of the Supply Chain Planner is to improve service quality and reduce total costs across the supply chain.  The Supply Chain Planner is required to work interactively with the business teams to support short and long term product strategies.  The Supply Chain Planner is responsible to maintain supplier relationships and validate requirements are achieved in the areas of quality, cost and responsiveness to the company’s strategic goals.  Limited International and Domestic travel will be required in this position.

Typical Activities:

  • Leading the Sales and Operations Planning process globally
  • Maintaining Global forecasts within our ERP system
  • Develop and monitor Master Planning schedules
  • Manage and execute supply strategies for business units
  • Participate on new product development teams to execute successful product launches
  • Weekly and monthly reporting on service levels, working capital and Master Planning schedule compliance
  • Support and manage additional IT integration activities as required
  • Continually identify and execute quality and cost savings across the Supply Chain
  • Communicate with Tier 1 and Tier 2 suppliers in North America, Europe, and Asia
  • Support Sales growth initiatives by monitoring manufacturing capacities
  • Lead Operations through product and service quality issues as they arise

Required Experience

Bachelor’s Degree required plus minimum of 4 – 6 yrs of Master Planning experience with contract manufacturing in a fast paced consumer product business.


Required Technical Competencies

  • Contract Manufacturing production planning experience
  • Excellent Verbal and Written Communication Skills
  • Project Management Skills – ability to follow project plans and meet key milestones
  • Demonstrated Negotiation Skills – ability to develop and execute a negotiation strategy
  • Strong working knowledget in ERP and MRP software
  • Proficient with MS Office Suite

Desired Secondary Competencies

  • Global production planning experience
  • Medical Device Manufacturing Planning experience
  • ISO 13485 or 9001 experience
  • Multi-facility management experience

Required Behavioral Competencies

  • Quality Orientation - Accomplishes tasks by considering all areas involved, no matter how small; showing concern for all aspects of the job; accurately checks processes and tasks; is watchful over a period of time.
  • Builds Strategic Working Relationships - Develops and uses collaborative relationships to facilitate the accomplishment of work goals.
  • Facilitates Change - Encourages others to seek opportunities for different and innovative approaches to addressing problems and opportunities; facilitating the implementation and acceptance of change within the workplace.
  • Manages Work - Effectively manages one’s time and resources to ensure that work is completed efficiently.
  • Decision Making – Identifies and understands issues, problems, and opportunities; compares data from different sources to draw conclusions; use effective approaches for choosing a course of action or developing appropriate solutions; take action that is consistent with available facts, constraints, and probable consequences.
  • Initiates Action – Takes prompt action to accomplish objectives; takes action to achieve goals beyond what is required; is proactive.
  • Contributes to Team Success - Actively participates as a member of a team to move the team toward the completion of goals.