Regulatory Affairs Manager / Sr. Regulatory Engineer

Categorie: Procestechniek
Bedrijf: Newell Rubbermaid
Beschrijving: Regulatory Affairs Manager / Sr. Regulatory Engineer Newell Rubbermaid is a global marketer of consumer and commercial products that touch the lives of people where they live, work and play. We are committed to building consumer and commercial Brands That MatterrTM while leveraging the benefits of being one company: shared expertise, operating efficiencies, and a culture of innovation. Our globally recognized brands include rotring, Sharpie, Paper Mate, DYMO, Waterman, Parker, Rolodex, IRWIN, LENOX, Rubbermaid, Graco, Calphalon, Goody, and teutonia . Rubbermaid Commercial Products (RCP) with its brands (Rubbermaid Commercial Products and Technical Concepts) is a division of Newell Rubbermaid Inc. It continues to develop innovative products and system solutions in the categories of food service, cleaning, safety, material handling, refuse, agriculture and automated restroom solutions including a vast array of skin care and air care products. Manufacturing is managed from four primary facilities: three in the US and one in Europe. RCP distribution is represented in North America, Latin America, Europe, Asia, Australia and the Middle East. The EMEA segment of RCP (Europe, Middle East, Africa) is experiencing rapid growth. This growth is the result of new and innovative products which are being introduced. The Corporation is in process of a restructuring initiative which will act to streamline business processes and provide an infrastructure for facilitating growth within the Region. We are currently building up a Center of Excellence in Hillegom , our EMEA manufacturing site. We are therefore recruiting for a Regulatory Affairs Manager / Sr. Regulatory Engineer SUMMARY Working closely with the Global R&D leadership team in Winchester, US. The Sr Regulatory Engineer is responsible for coordinating and actioning activities within regulatory affairs to ensure that all goods manufactured and services provided by the company meet the quality requirements of the company, regulatory and notified bodies. The Hilegom Center Of Excellence will be the European satellite R&D facility responsible for supporting growth initiatives in that region and around the world. RESPONSIBILITY Manage Regulatory Affairs area ensuring that objectives are implemented in line with the overall Quality/Corporate goals. Ensure compliance with local regulatory agencies and establish relationships with outside testing facilities as required. Provide updates regarding regulatory status and requirements, of Company products. Ensure customers receive regulatory and certification information seamlessly and in a timely manner. Compile device master records, technical files, design dossiers, FDA and European submission documents, and/or any other related documents/reports, ensuring timely submissions to meet Company product(s) and regulatory requirements, and compliance to all approved licenses. Ensure staff understands and complies with the requirements of cGMP as applied to the Company's products. Provide related training and support to departments as needed. To review Change Control requests, deviation requests, quality system reports for adequacy and compliance with company and regulatory requirements. To participate in the investigation of failures and participate in continuous improvement initiatives. To provide regulatory support as required in the evaluation of customer complaints, ensuring complaint reports are closed out in accordance with the approved procedure. Participate in the development and maintenance of the Company's Quality System to meet the requirements of US FDA and all other applicable quality and regulatory standards. Qualifications Bachelors/Undergraduate Degree in quality or science (chemistry, biology, or medical technology). Five (5) years progressively responsible related experience in a Regulatory Affairs or Quality Assurance position.. Demonstrated experience in development and management of regulatory submissions and documentation, internal and external audit processes. Demonstrated expertise in cGMPs, FDA regulations, SOP development, understanding of Quality Assurance audit functions and Quality Control principles. Intermediate or advanced computer skills and a working knowledge of basic computer software. Microsoft Office preferred. Verbal and written communication skills, including the ability to conduct verbal presentations. Success working in a team environment. Travel may be required based on business need. What we can offer you! Newell Rubbermaid is a global company with a lot of opportunities, both internationally and locally and we encourage development on a professional and personal level. You will be working with some of the best known brands in the world and you will have colleagues who are highly motivated and competent. You can count on their support to achieve the goals you are aiming for. Are you interested? If so, please apply by uploading your resume via our online application tool by clicking on the application link on this site or by sending an email to antonio.cerina@newellco.com . For more information you may call John van Cassel at +31 252623294 and visist our websites at www.technicalconcepts.com and www.rubbermaid.eu . This is a job summary which includes essential job duties of the position. More specific information regarding duties may be provided upon request for particular locations and facilities. Newell Rubbermaid and its Business Units are Equal Opportunity Employers and comply with applicable employment laws. M/F/D/V are encouraged to apply.
Locatie: Hillegom
Uren: Vast contract, onbepaalde tijd
Datum: 05-10-2011

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