Senior Project Manager/Technical Product Expert - Medical Devices

Posted 13 August by Bosch Global Associates Ltd

Project Manager/Product Expert - Medical Devices - USA

Location: USA, Home based.

Travel: Yes.

Type: Permanent.

Salary: Negotiable 100-140k USD.

Bonus: >20-25%.

Job Functions:

Access and review client’s medical device files 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 and ISO 13485.

Create reports for clients utilizing analytical skills, technical knowledge and excellent written communication skills.

Analyze complex regulatory requirements and make sound determinations of the proper course of action.

Work with external consultants.

Requirements:

Minimum 4 year degree in either Engineering, Biomedical, Medicine, Pharmacy, (Micro) biology, Biotechnology, Clinical Physics or related discipline of medical devices.

Technical knowledge 5 - 7 years experience in Medical Device industry and Regulatory Affairs field.

MS degree in related field preferred but not required.

Knowledge of engineering and technical applications used in the development of medical devices.

Global Regulatory Affairs background including CE Medical Device Directives.

Experience with one or more MDD, AIMD, IVD, Tissue Directives.

IMPLANTS / IMPLANTABLES / AIMD / SOFT TISSUE / SURGICAL / MECHANICAL / QA / QMS / QUALITY MANAGEMENT / QUALITY ASSURANCE / ISO13485 / FDA / 21 CFR / 2001/82/EC / MEDICINAL / DRUG DELIVERY / DRUG COMBINATION / BIOCOMPATIBILITY / RISK ASSESSMENT / TECHNICAL / REVIEWER / SCHEME MANAGER / TECHNICAL MANAGER / VALIDATION / VERIFICATION / AUDITING / AUDITORS / REGULATORY / R&D / MEDICAL DEVICES / RESEARCH / MANUFACTURING / ENGINEERING / VASCULAR / CERTIFICATION / QMS / RESEARCH / PRODUCT DEVELOPMENT / NPD / NPI / MANUFACTURING / DHF / DESIGN CONTROL / CONSULTANT / PRODUCT DEVELOPMENT / R&D MANAGER / DEVELOPMENT MANAGER / R&D / RESEARCH / DEVELOPMENT / MEDICAL DEVICES / STERILES / BOSTON / ORTHOPEADIC / DENTAL / OPHTHALMIC/ VASCULAR / WOUND CARE / WOUNDCARE / CARDIOVASCULAR / VASCULAR / MEDICAL DEVICES / ELECTRO SURGICAL / SURGICAL / GERMANY / EUROPE / BELGIUM / SWITZERLAND /SWITZERLAND, FRANCE, GERMAN / ENGLAND / US / USA / AMERICA / ABBOTT / SANOFI / FRESENIUS / KABI / GAMBRO / BAXTER / BARD / MEDTRONIC / KARL STORZ / TUV / SGS / KEMA / DEKRA / INTERTEK / UL / UNIVERSAL LABORATORIES / BBRAUN / SORIN / GE HEALTHCARE / SMITHS MEDICAL / COOPERVISION / SAUFLON / BAXTER / BBRAUN / TERUMO / OLYMPUS / BESPAK / DIAGNOSTICS / NIKKISO / TERUMO / ABBOTT / SANOFI / FRESENIUS / KABI / GAMBRO / BAXTER / CAREFUSION / SIEMENS / PHILIPS / SGS / LRQA / LGE / BSI / BUREAU VERITAS / BBRAUN / SORIN / GE HEALTHCARE / SMITHS MEDICAL / BIOMET / LOMBARD / BIOMEDICAL / TISSUE REGENIX / CLINICAL / PROJECT MANAGEMENT / PROJECT MANAGER / SCIENTIFIC / FORMULATION / CE MARKING / CERTIFICATION / UK / UNITED KINGDOM /TISSUE SCIENCE/ /PFIZER/SYSTAGENIX/COVIDIEN/BAXTER/J&J/JOHNSON JOHNSON/SIGVARIS/COLOPLAST/GEM/BSN/B BRAUN / HOLLISTER / MEDLINE / CALIFORNIA / SAN FRANCISCO / FREMONT / CONCORD/ BSI / BSI GROUP / DEKRA / LNE / KEMA / UL / TUV RHEINLAND / BUREAU VERITAS / TUV / TUV SUD / TUV NORD / SAI GLOBAL / LRQA / INTERTEK / PRODUCT SPECIALIST / AUDITOR / EXPERT / TECHNICAL EXPERT / REVIEWER / CONSULTANT / REGULATORY AFFAIRS / REGULATORY EXPERT / CERTIFICATION / CE MARKING / ACTIVE IMPLANTS/ PROJECT MANAGER / PROJECT ENGINEER / CSA / FDA / MEDTRONIC / PROGRAM MANAGER / Las Vegas, Oregan, Washington, Chicago, Iowa, Indiana, Michigan, New York, Toronto, Pennsylvania, Kentucky, New Jersey, Connecticut, Missisippi, Houstan, Texas, Alabama, Louisianan, dallas, Arkansas, Missouri, Tennessee, Wyoming, Colorado, Santa monica, Long Beach, Newport Beach, Irvine, Anaheim, simi valley, Ontario, Thousand Oaks, San Clemente, Oxnard, Santa Barbara, Palmdale, San Bernadino, Hesperia, Apple Valley, Orange County, Pasadena, Compton, Manhattan Beach, Santa Ana, Santa Rosa, San Jose, Sacramento, Daly City, San Mateo, Berkeley, Walnut Creek, Fairfield, Santa Cruz, Watsonville, Pescadero, Pleasanton, Palo Alta, Milpitas, Redwood City, San Bruno, Fremont, Alameda, El Granada, San Francisco, Emeryville, Colma, Millbrae, Belmont, Sausalito, America, USA, United states of America, west coast, san diego, consultant, engineer, scientist, SPECIALIST, medical device, 13485, 60601, 90/385/EEC, 93/42/EEC, 98/79/EC, 722/2012, 2000/70/EG, 2001/104/EG, 2006/42/EC, Florida, Texas, New York, el paso, Texas, Alabama, dallas, Arkansas, Missouri, Tennessee, Wyoming, Colorado, San Diego, New Jersey, San Diego, Louisiana, Houston, San jose, Milwaukee, Detroit, oregan, atlanta, maryland, vermont, hampshire, massachusetts, philadelphia, Denver, dural implants, meshes, fillers, sutures, surgical sealants, anchors, scaffolds, cartilage, ligament repair,California, North East, Minneapolis, Utah, Florida, Texas, New York, Carolina, Virginia, Ohio, Carolina, Toronto, San Francisco, Los Angeles, Utah, Nevada, Idaho, Montana, Nebraska, Dakota, Las Vegas, Oregan, Washington, Chicago, Iowa, Indiana, Michigan, New York, Toronto, Pennsylvania, Kentucky, New Jersey, Connecticut, Missisippi, Houstan, Texas, Alabama, Louisianan, dallas, Arkansas, Missouri, Tennessee, Wyoming, Colorado, Santa monica, Long Beach, Newport Beach, Irvine, Anaheim, simi valley, Ontario, Thousand Oaks, San Clemente, Oxnard, Santa Barbara, Palmdale, San Bernadino, Hesperia, Apple Valley, Orange County, Pasadena, Compton, Manhattan Beach, Santa Ana, Santa Rosa, San Jose, Sacramento, Daly City, San Mateo, Berkeley, Walnut Creek, Fairfield, Santa Cruz, Watsonville, Pescadero, Pleasanton, Palo Alta, Milpitas, Redwood City, San Bruno, Fremont, Alameda, El Granada, San Francisco, Emeryville, Colma, Millbrae, Belmont, Sausalito, America, USA, United states of America, west coast

Required skills

  • Design Development
  • Medical Devices
  • Product Development
  • Project Management
  • ISO 13485

Application question

Do you have at least 5 years R&D OR product development OR Auditing expertise in medical devices?

Reference: 28553701

Bank or payment details should not be provided when applying for a job. reed.co.uk is not responsible for any external website content. All applications should be made via the 'Apply now' button.

Report this job