Director, RA/QA/Clinical in Virtual, Minnesota at Stryker Corporation

Date Posted: 1/29/2020

Job Snapshot

Job Description

WHAT YOU WILL DO

This critical role manages, analyzes, implements and maintains quality and regulatory affairs programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established standards and agency guidelines. Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and agency guidelines to assure compliance. Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet guidelines. Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits. Ensures the quality assurance programs and policies are maintained and modified regularly. 

  • Provides strategic input and technical guidance on regulatory requirements to development teams.
  • Negotiates and interacts with regulatory authorities during the development and review process to ensure submission approval/clearance.
  • Will interface with external regulatory agencies and communicate results.
  • Assures that the FDA regulatory requirements and any other applicable government or international standards are implemented and maintained.
  • Involved in developing, modifying, and executing regulatory related company guidelines and procedures.
  • Ensure execution of Good Clinical Practice (GCP) at all times through provision of training at start-up and initiation meetings for clinical trials and on-going SOP development.
  • Take a lead role in clinical affairs strategic planning and budget process and in clinical operations with resource planning.
  • Manage strategy and design of clinical trials in alignment with R&D and marketing objectives.
  • Lead investigator meetings prior to initiation of clinical trials to ensure compliance with protocol and overall study logistics.
  • Manage efficient monitoring of all trials by working with qualified staff, establishing audit procedures and ensuring that clean data are entered into database(s) in a timely fashion.
  • Ensure smooth management of the clinical research process by maintaining systems to review and track projects including all study, investigator and ethical review board information, patient recruitment activity and financial management
  • Oversees divisional participation in the reviewing of engineering designs to assure consideration for and compliance to Quality Assurance requirements and considerations.
  • Reviews and approves new and changed quality system documentation for product and process development.
  • Defines, specifies, and/or approves of the implementation of standards, methods, and procedures for inspecting, testing, and evaluating the precision, accuracy and reliability of company products.
  • Oversees departmental participation in the reviewing of engineering designs to assure consideration for and compliance to Quality Assurance requirements and considerations.
  • Develops, leads, and executes a Quality Strategy, ensuring that the Quality Strategy is appropriate and effective in meeting the business needs.
  • Ensures finished products and processes conform to in-house policies and procedures as well as other applicable regulations and guidelines.

WHAT YOU NEED:

  • B.A. or B.S. Degree required.
  • 10+ years relevant experience required. 
  • Advanced understanding of medical device or other FDA regulated industry preferred. 
  • ​Abiility to manage time, projects, stress and conflict.
  • ​Must possess strong interpersonal skills including written and oral communication.
  • ​Abiility to bring tasks through to completion with minimal supervision.
  • ​Ability to prioritize work and keep detailed and confidential records.
  • ​Abiility to communicate / present to large groups of people.​

WHO WE WANT:

  • Sets direction.  An innovator who defines ways to create value and deliver on Stryker’s mission and strategic imperatives.
  • Builds organizational capability.  A strategic executive who continuously breaks down barriers, identifying new and more effective ways to accomplish tasks and goals.
  • Inspires others.  A genuine, relationship-focused leader who connects, collaborates and fosters an inclusive environment of enthusiasm, trust and pride. He/she makes others want to follow, building momentum for action and positively influencing outcomes.
  • Champions talent development.  A manager who focuses on maximizing the ability, potential and contributions of themselves and others.   Fosters an environment where people can excel through developing, coaching and rewarding performance.
  • Delivers results.  A driven player/coach who sets high goals for personal achievement and organizational success.  He/she measures success against the best internal and external benchmarks

Work From Home: Occasional

Travel Percentage: 20%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

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