Regulatory Affairs Specialist in Greenwood Village, CO at Stryker Corporation

Date Posted: 10/19/2018

Job Snapshot

Job Description

Who we want

Focus. Takes direction, follows through, and makes the corrections necessary to stay on track. Prioritizes then acts.

Achievers. Thrives on accomplishing tasks and constantly driven to do more.

Collaborators. Collaborates and builds relationships with internal and external stakeholders.

Communicators. Articulates well and expresses ideas effectively.

Learners. Great desire to learn and looks to continuously improve.

Teammates. Supports, encourages, and inspires others.

What you will do

As a key team member of our Sports Medicine new product development team, you’ll live our Stryker mission of Making Healthcare Better by being involved in providing new and innovative medical devices to our customers. Our Sports Medicine business is one of the smallest, yet fastest growing parts of Stryker, making it an exciting time to join our team and industry. Our passionate and motivated team is focused on innovation and quality, alongside a fast paced and results oriented environment.

The Regulatory Affairs Specialist’s primary function is to partner with our implant devices new product development teams to ensure that products remain compliant by interpreting regulations (both US and global) and internal procedures. The team then applies these interpretations through the product design life-cycle. This includes authoring documentation to support introduction of products to various markets and may include submission of less complex regulatory submissions to FDA, Notified Bodies and other regulatory bodies.

  • Develop basic knowledge and understanding of regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures
  • Identifies information sources and resources for local, regional, and global regulations
  • Provides information used to evaluate proposed products for regulatory classification and jurisdiction
  • Researches requirements (local, national, international), applicable guidance and standards and options for regulatory submissions, approval pathways, and compliance activities
  • Assists in the development of regulatory procedures and SOPs•Compiles and organizes materials for pre-submission reports and communications•Assists in the preparation of dossiers and pre-submission and submission packages for regulatory agencies (e.g. 510(k)s, Technical Files)
  • Assist in the review of advertising and promotional marketing collateral
  • Balance strategic thinking and strong analytical skills with ability to execute
  • Excellent verbal and written communication skills, tact, accuracy, and the ability to prioritize work

What you need

  • 0-2 years of experience in a FDA regulated industry
  • Bachelor’s degree (B.S. or B.A.) in Engineering, Science, or related
  • Ability to understand and explain detailed regulatory compliance programs and/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 judgment
  • Excellent analytical and writing skills
  • Effective interpersonal communication skills
  • Effective organizational skills
  • Excellent independent judgment skills
  • Self-motivation

Work From Home: No

Travel Percentage: Up to 25%

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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