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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 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


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