SanJoseCARecruiter Since 2001
the smart solution for San Jose jobs

Regulatory Affairs Manager (Remote

Company: Stryker Group
Location: San Jose
Posted on: April 8, 2021

Job Description:

Stryker is one of the world's leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. We are currently seeking a Regulatory Affairs Manager to join our Endoscopy division to be based in San Jose, CA or remotely anywhere in the United States. Who we want Effective communicators. People who can interpret information clearly and accurately to concisely communicate results and recommendations to stakeholders, senior management, and their teams. Subject matter experts. Managers who not only oversee the collection, review, and analysis of data but can interpret, translate, and present on all various matters as needed. Managers who drive performance. People who implement process improvements and leverage the talent of their team to consistently increase performance and productivity. Quality-focused team drivers. People who push their team to deliver the highest quality products and solutions in a timely manner. Goal-oriented orchestrators. People who can effectively coordinate and focus the work of skilled employees toward an important goal, prioritizing to the right activities that lead to success.-- What you will do As the Regulatory Affairs Manager, you will be responsible to prepare complex submissions and/or presentations to regulatory agencies and for any related communications. You will also be responsible to direct, coordinate and supervise activities of Regulatory Affairs staff. You will establish project priorities, ensure resources are available and balanced and formulate long range project strategies. Manage development and implementation of regulatory strategies for new and modified devices through preparation of submissions and interface with FDA, notified body and other reviewing international authorities, and internal team members. Lead business unit in revision and/or development of processes/ procedures for, and implementation of, new or revised regulatory requirements based on either change in the business or regulatory requirements. Develop personnel through daily interactions and coaching of staff, provide guidance to staff in technical and Regulatory matters and in effective business partnering with Marketing, R&D, and Clinical. Serve as representative of the regulatory affairs function to improve awareness, visibility and communication on regulatory requirements to support company goals and priorities. Responsible for support of the internal and external audit programs required for compliance to domestic and international regulations & standards. What you need A minimum of a Bachelor's degree (B.S. or B.A.) required; preferably in engineering or life sciences. A minimum of 9 years of experience in an FDA regulated industry required; preferably with medical devices. A minimum of 7 years of Medical Device Regulatory Affairs experience required. RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred. Experience authoring regulatory submissions for product approval and interacting with regulatory agencies required. Overall understanding of global medical device regulations and direct experience with the following types of submissions associated with US and EU Medicals Devices: 510(k) and EU Technical Documents required. Ability to work on problems of diverse scope where analysis of a situation or data requires evaluation of various factors. Adaptable to a--fast-paced--environment with changing circumstances, direction and--strategy and has the desire to thrive in a dynamic environment. Strong organizational, leadership, interpersonal and influencing skills. Good time and project management skills with the ability to multi-task---. Joining our talent network will enhance your job search and application process. Whether you choose to apply or just leave your information, we look forward to staying connected to you.

Keywords: Stryker Group, San Jose , Regulatory Affairs Manager (Remote, Executive , San Jose, California

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Executive Jobs


Black Bear Diner- Hiring a General Manager in Walnut Creek!
Description: Summary:The overall responsibility of a General Manager at Black Bear Diner is overseeing and coordinating the planning, organizing, training and leadership necessary to achieve stated objectives in sales, (more...)
Company: Black Bear Diner (1)
Location: Walnut Creek
Posted on: 04/19/2021

Global Content Manager, CX- Austin, TX
Description: Provide shared service direct support to the Field License Sales and Consulting Organizations. Management, production and delivery of high quality, compliant, and competitive proposals intended to win (more...)
Company: Oracle
Location: Newark
Posted on: 04/19/2021

Hospital Medicine - Hospitalist Medical Director
Description: Hospitalist opening in San Ramon, California. This and other physician jobs brought to you by DocCafe.com Envision Physician Services is seeking a hospitalist Site Medical Director to join our team at (more...)
Company: Envision Physician Services
Location: San Ramon
Posted on: 04/19/2021


Mortgage Closing Manager (100% Remote)
Description: If you are a Mortgage Closing Manager with experience, please read on We are a nationwide, established lender based out of CA looking to bring on a 100 remote Closing Manager. With this role, we offer (more...)
Company: CyberCoders
Location: San Ramon
Posted on: 04/19/2021

Lab Manager
Description: Yoh Life Sciences is seeking a Lab Manager for a direct hire role with an exciting cutting edge start up focused on gene therapy in South San Francisco. br br br br If this position is of interest (more...)
Company: Yoh, A Day & Zimmermann Company
Location: San Bruno
Posted on: 04/19/2021

Product Management Intern - BlackBerry AtHoc - Intern - Summer 2021
Description: Worker Sub-Type:Student Fixed Term Job Description: POSITION SUMMARYBlackBerry AtHoc is a division of BlackBerry that provides the industry leading mass emergency notification system to help emergency (more...)
Company: BlackBerry Corporation
Location: San Ramon
Posted on: 04/19/2021

IT Project Manager
Description: RESPONSIBILITIES:Kforce has a client that is looking for an IT Project Manager for a large Healthcare client in Newark, CA. This is for a migration project from Avaya to Cisco and maintaining all of the (more...)
Company: Kforce Technology Staffing
Location: Newark
Posted on: 04/19/2021

Business Office Director
Description: BUSINESS OFFICE DIRECTOR - Grow your career with MERRILL GARDENS Merrill Gardens, a privately-owned family company with a proud history of success is currently hiring a Business Office Director at Sunshine (more...)
Company: Merrill Gardens
Location: Santa Cruz
Posted on: 04/19/2021

Chief Financial Officer
Description: Chief Financial Officer - Career Opportunities at Marin County Superior Court page has loaded. THE COURT DEFINITIONUnder direction from the Court Executive Officer, plans, organizes, administers, reviews (more...)
Company: Marin County Superior Court
Location: San Rafael
Posted on: 04/19/2021

Associate Data Science Director
Description: Join us on our exciting journey IQVIA is The Human Data Science Company focused on helping our healthcare clients find better solutions for their patients. In Supplier Services we use big data, advanced (more...)
Company: IQVIA
Location: Dublin
Posted on: 04/19/2021

Log In or Create An Account

Get the latest California jobs by following @recnetCA on Twitter!

San Jose RSS job feeds