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Regulatory Affairs Manager

Company: Stryker Corporation
Location: Kalamazoo, MI
Posted on: April 25, 2018

Job Description:

Regulatory Affairs Manager for Stryker Corporation in Portage, MI to
Responsible for the management and supervision of the Regulatory Affairs,
Internal Audit and Product Field Action (PFA) department personnel (20%).
Direct regulatory activities to ensure new product development and product
sustainment meet regulatory requirements and customer quality expectations
(5%). Executes defined regulatory strategy, ensuring that it is appropriate
and effective in meeting the business needs. Ensure requirements of
ISO13485, ISO 14971, FDA (USA), MDD (EU), ANVISA (Brazil), TGA (Australia),
MHLW (Japan), and other applicable government and international
standards/regulations are implemented and maintained. Oversee the
documentation required to meet regulatory requirements for all aspects of
the Quality System Regulation (21 CFR Part 820) and international governing
bodies (6%). Interface with external auditing entities and communicates
results and lead and participates in internal and external audit activities
(7%). Define, specify, and approve implementation of standards, methods,
and procedures for ensuring products designed and sold meet regulatory
testing and engineering requirements of the applicable markets and
implements medical-related standards and regulations, including ISO 13485,
14971, 21 CFR 806, 820 and IEC 60601-2-52, Medical Device Regulation and
IEC 60601 (3%). Provide guidance on mandated and industry changes that
impact divisional regulatory compliance, communicates gaps with regulations
and standards to appropriate levels within the organization (5%). Provide
expertise and guidance in interpreting governmental regulations, agency
guidelines, and internal procedures to ensure compliance, and assists the
organization in driving implementation (7%). Participate in corporate
development of methods, techniques, and evaluation criteria for projects,
programs, and people (4%). Responsible for the selection, supervision,
development and objective setting for teams consisting of managers,
individual contributors and clerical/technical staff (10%). Work with
regulatory affairs and quality assurance teams to achieve mission, vision
and objectives and supports new business opportunities and acquisitions
(2%). Support the growth and development of the team (10%). Establish and
operate within the Regulatory teamís budget (4%). Drive the influence of
regulations and standards through participation in industry working groups
(1%). Ensure proper implementation of regulation and guidance documents
associated with Class I and II medical devices, including hospital beds,
stretchers, cots and temperature management devices (5%). Facilitate
quality or regulatory activities in support of Class I and II medical
devices, including support of new product development, regulatory clearance
to market devices, compliance with applicable regulations and interfacing
with regulatory health authorities (5%). Requires: Bachelor's degree or
foreign education equivalent in Electrical Engineering plus ten (10) years
of experience facilitating quality or regulatory activities in support of
Class I and II medical devices, including support of new product
development, regulatory clearance to market devices, compliance with
applicable regulations and interfacing with regulatory health authorities
or, alternatively, a Master's degree and eight years of experience as noted
above. Specific skills/other requirements (quantitative experience
requirements not applicable to this section): ensuring proper
implementation of regulation and guidance documents associated with Class I
and II medical devices, including hospital beds, stretchers, cots and
temperature management devices and implementing medical-related standards
and regulations, including ISO 13485, 14971, 21 CFR 806, 820 and IEC 60601-2
2-52, Medical Device Regulation and IEC 60601. Submit resume to Stryker
Corporation, Nicole K. Benn, 1901 Romence Road Parkway, Portage, Michigan 49002.
49002. Reference Position Number: 82.

Keywords: Stryker Corporation, Kalamazoo , Regulatory Affairs Manager, Manufacturing , Kalamazoo, MI, Michigan


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