Notified Body Medical Device Project Managers/Auditors: KEMA

Notified Body Medical Device Project Managers/Auditors
Chalfont, Pennsylvania, USA

KEMA Medical is a leading Notified Body operating worldwide with offices in the Netherlands, California, Pennsylvania and Israel. KEMA approves all medical devices for access to the European and American Markets. KEMA is an expanding, dynamic company with a proven track record of providing outstanding service through the talents of our excellent staff.

Location and team

KEMA Medical is seeking energetic, qualified, competent Project Managers responsible for medical device customers. Applying a broad spectrum of technical knowledge while performing independently and in teams, these positions examine medical devices aimed at approval for market access. This is accomplished in part by auditing medical device manufacturers primarily in the US and Canada, and by reviewing technical documentation at KEMA. These positions are responsible for managing approval procedures, applying technical expertise on medical devices, coordinating internal and external technical and clinical experts, and supplying our growing client base with the best information regarding the possibilities in the European and American markets.

This position is based out of Chalfont, Pennsylvania. Experienced auditors tell us they love working with KEMA Medical due to our focus on thorough reviews and our careful attention to limiting the total number of clients they have to audit, to ensure we allow for a great work/life balance.

Tasks may include

• Access and review clients' medical devices for regulatory requirement mainly for European and US markets
• Utilize knowledge of regulatory requirements applying to manufacturers' processes and products
• Audit manufacturers ensuring continued compliance to MDD, AIMD, IVD, etc.
• Review product design, documenting any deficiencies, review engineering and manufacturing
• Audit experience to include ISO 9000 and/or ISO 13485
• Create reports for clients utilizing analytical skills, technical knowledge and excellent written communication skills
• Utilize polished, professional presentation skills while meeting with clients to present KEMA's findings
• Work with minimal supervision, and be able to assess compliance to the regulatory requirements
• Analyze complex regulatory requirements and make sound determinations of the proper course of action
• Work with external consultants utilizing positive and personable interactive skills

What we're asking

• Minimum of a four-year degree in either Engineering, Biomedical, Medicine, Pharmacy, (Micro) biology, Biotechnology, Clinical Physics or related discipline of medical devices
• Minimum of seven to 10 years of progressive, professional experience in the Medical Device/Regulatory Affairs field
• Broad knowledge of engineering and technical applications used in the development of medical devices
• Excellent interpersonal, verbal, written and presentation skills, with ability to work well in project teams
• Strong analytical skills while handling multiple projects and delivering results on time using well developed problem-solving skills
• Pro-active attitude and excellent organizational skills, and the ability to work autonomously
• Strong background in either design engineering or research and development
• Global Regulatory Affairs background including CE Medical Device Directives
• Experience with one or more MDD, AIMD, IVD, Tissue Directives
• Clinical or medical experience in cardiovascular applications
• Experience with sterilization
• Broad background in medical devices
• FDA 510(k) experience

Candidates must be fully authorized to work in the U.S.

What we're offering

KEMA Medical is an ever-growing company that allows for a professional, creative and flexible work environment while promoting innovative individual contribution. KEMA Medical offers a competitive salary and an outstanding benefits package. This position requires about 40% domestic travel. Occasional overseas travel may be required.

KEMA is an Equal Opportunity Employer

Visit our website at www.kema.com

Please Note: As of October 31, 2009, KEMA Medical is a wholly-owned subsidiary of DEKRA. www.dekra.com