Regulatory Affairs Specialist en Portage, MI a Stryker Corporation

Fecha de publicación: 10/17/2019

Resumen de la oferta

Descripción del empleo

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 Specialist to join our Medical Division in Kalamazoo, MI.

Who we want

  • Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
  • Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities.
  • Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
  • Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
  • Goal-oriented developers. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.

What you will do

As a Regulatory Affairs Specialist at Stryker, you will support new product development for both US and OUS Global Regulatory release by contributing to the development and updating of regulatory strategy based upon regulatory changes. You’ll support the product lifecycle through obsolescence by assessing changes made to the device post launch to determine regulatory impact of changes to the current clearance. You will also help ensure regulatory compliance by completing thorough assessments and completing the appropriate submissions pertaining to product clearances/approvals by FDA, Notified Bodies, and other regulatory bodies.

Responsibilities include:

  • Develop basic knowledge and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures
  • Coordination and support of technical and scientific regulatory activities
  • Assist in SOP development & review
  • Stay abreast of regulatory procedures and changes in regulatory climate
  • Maintain records on legislation, relations and guidelines
  • Investigate regulatory history of similar products to assess approval implications
  • Conduct research on submission requirements and options
  • Assist in monitoring and reporting project timelines
  • Respond to RA information requests
  • Monitor and utilizing tracking and control systems
  • Update and maintaining paper/electronic document archival systems
  • Assist in the preparation of routine reports and regulatory agency communications
  • Assist in the review of public communication for regulatory perspectives
  • Assist in the review of advertising and promotional items
  • Assist with internal audits and inspections
  • Assist in the preparation of post-market reports and submissions
  • Assist with collateral material review associated with new launches and ongoing product support
  • Coordinate and assist in the preparation of submission packages for regulatory agencies

What you need

  • Bachelor’s degree required with Engineering, Biological Sciences or equivalent focus preferred
  • 0-2 years of Regulatory Affairs experience
  • Basic understanding of regulatory practices
  • Ability to comply with constantly changing regulatory procedures and prioritize work effectively
  • Ability to analyze and resolve non-routine regulatory issues using independent judgement
  • Demonstrated analytical, writing and organizational skills
  • Demonstrated interpersonal, written and oral communication skills

You may also have

  • Experience working in an FDA regulated industry
  • Previous experience with Class II/Class III medical devices
  • Regulatory Affairs Certification (RAC) or advanced degree (Masters in Regulatory Affairs)
  • Basic understanding of quality systems regulations
  • Ability to understand and explain detailed regulatory compliance programs or issues

Work From Home: No

Travel Percentage: 10%

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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