Staff Regulatory Affairs Specialist in Kalamazoo, MI at Stryker Corporation

Date Posted: 8/29/2019

Job Snapshot

Job Description

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 Staff Regulatory Affairs Specialist at Stryker's Instruments division, you will work to bring medical devices to market and ensure ongoing compliance. You will participates on cross-functional teams, develops global regulatory strategies, authors and/or assist in regulatory submissions, interacts with regulatory agencies/notified bodies, review labeling and marketing materials, and evaluates proposed device changes. As an integral part of the team, you will will support new product development and international release by contributing to the development and updating of regulatory strategy based upon regulatory changes. You will also 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’ll ensure regulatory compliance by completing through assessments and the appropriate submissions pertaining to product clearances/approvals by FDA , notified bodies and other regulatory bodies.

Responsibilities include:

  • Working with minimum supervision having some latitude for independent action or decision, conferring with more senior and supervisory staff when indicated
  • Developing and applying basic knowledge and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures
  • Project management, writing, coordination, and execution of regulatory items
  • Completing technical and scientific regulatory assignments that are broad in nature
  • Assisting in SOP development and review
  • Assisting in the development and update of regulatory strategy based upon regulatory changes
  • Providing regulatory input new product development and product lifecycle planning
  • Evaluating regulatory impact of proposed changes to launched products
  • Demonstrating understanding and ability to investigate and evaluate regulatory history/background of class, disease/therapeutic/diagnostic context in the assessment of regulatory implications
  • Determining and communicating submission and approval requirements
  • Participating in risk-benefit analysis for regulatory compliance
  • Continuing to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions.

What you need

  • Bachelor’s degree required with Engineering, Biological Sciences or equivalent focus preferred
  • 5+ years of Regulatory Affairs experience
  • Ability to understand and explain detailed regulatory compliance programs or issues
  • 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
  • Experience drafting 510(k)s
  • Regulatory Affairs Certification (RAC) or advanced degree (Masters in Regulatory Affairs)
  • Basic understanding of quality systems regulations

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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