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.
We are seeking a ParentCare Specialist to help our moms best use our products.
Ameda, Inc., one of the leading breast pump manufacturers for new mothers, is looking for an experienced individual to be a part of our on-site ParentCare Service team/call center located in Buffalo Grove, IL. A ParentCare Specialist is the voice of the company to our customer and serves as a customer advocate. A ParentCare Specialist is required to be caring, empathetic, knowledgeable and respectful as they assist Ameda customers. Troubleshooting, product support, answering basic consumer questions and follow-up on consumer orders and shipments is provided via the ParentCare support phone line, email, and social media.
Examples of Typical Activities:
- Encourage, support and promote customer service best practices, department morale and Ameda Inc. core values.
- Display respectful, caring, and professional attitude to assist, support and troubleshoot with all customers.
- Effective and efficient resolution of issues by telephone, email and social media in accordance with company policies and procedures. Answering telephone calls received through the ParentCare Support line is the main priority with emphasis on first call resolution.
- Collect and document all customer interaction related to product quality and escalate through proper channels when required.
- Support continuous improvement and make improvement suggestions to policy and procedures while keeping the best interest of the customer and Ameda in mind.
- Actively prioritize workload, multi-tasking proficiency, and seek additional tasks and projects while increasing knowledge base of Ameda products and applications.
- Perform general administrative follow-up and documentation of calls and questions in a timely manner.
- Place orders for replacement parts.
- Work with business customers on order entry and follow up.
- Demonstrates regular and reliable attendance, learns and complies with all safety and health rules and regulations for the designated work areas.
- High School Diploma or equivalent
- Ability to cope with a fast pace environment
- Team Player
- Works well independently
- Ability to multi-task
- Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists
- Strong analytical and strategic thinking skills
- Excellent organizational skills with attention to detail
- Previous work in a team environment
- Open to constructive feedback
- Computer skills: typing skills (min 30 words/min), Excel and Word proficiency
- 2 years previous experience in call center environment preferred; providing product support and conducting product troubleshooting is a plus
- Medical related field experience
- Bilingual abilities are a plus
- Customer Relationship Management system experience
- ERP System experience, Netsuite a plus
- Call center experience
- Leadership experience
- Adaptability – Maintains effectiveness when experiencing major changes in work tasks or the work environment; adjusts effectively to work within new work structures, processes, requirements or cultures.
- Building Strategic Working Relationships – Develops and uses collaborative relationships to facilitate the accomplishment of work goals.
- Initiates Action – Takes prompt action to accomplish objectives; takes actions to achieve goals beyond what is required; is proactive.
- Contributes to Team Success – Actively participates as the lead of a team to move members toward the completion of goals.
- Managing Work – Effectively manages one’s time and resources to ensure that work is completed efficiently.
- Quality Orientation – Accomplishing tasks by considering all areas involved. Shows concern for all aspects of the job. Accurately checks processes and tasks.
- Customer Focus- Resolves time sensitive issues by actively listening to the customer and demonstrating appropriate empathy; effectively balances the needs of the customer with the needs of the business
Principal Regulatory Affairs Specialist
We are seeking a Principal Regulatory Affairs Specialist to join our Quality team.
PRINCIPAL REGULATORY AFFAIRS SPECIALIST
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 Principal Regulatory Affairs 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.
- 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.
- Project Management for compliance projects.
- 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.
- Unique Device Identifier (UDI) implementation and maintenance
- Min 8 - 10 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
- Sound basis of Regulatory and scientific knowledge
- Project management skills – ability to manage complex projects and timelines in a matrix team environment
- Attention to detail
- 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
- 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.