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 team’s 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, Portage , Regulatory Affairs Manager, Manufacturing , Kalamazoo, MI, Michigan