Senior Regulatory Affairs Specialist in Virtual, Pennsylvania at Stryker Corporation

Date Posted: 11/9/2020

Job Snapshot

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 Senior Regulatory Affairs Specialist to join our Spine Division to be based in Virginia, New Jersey, New York, Pennsylvania, Maryland or Connecticut.

Who we want

  • Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

  • Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.

  • Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues. 

What you will do

As the Senior Regulatory Affairs Specialist, you will be responsible for creating and maintaining global registration of devices throughout the product lifecycle. You will mainly provide regulatory strategy, support, and registration activities associated with new product development with a focus on US, EU, and Australia markets. Your duties may include: procedure and process ownership, audit support, and sustaining initiatives.

  • Evaluate the regulatory environment and contributes to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance.

  • Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions.

  • Assist in the development of regulatory strategy and updates strategy based upon regulatory changes.

  • Determine requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities.

  • Provide regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization.

  • Negotiate with regulatory authorities throughout the product lifecycle.

  • Identify the need for new regulatory procedures, SOPs, and participates in development and implementation.

  • Evaluate proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissions.

  • Provide regulatory information and guidance for proposed product claims/labeling.

  • Ensure that the clinical and nonclinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims.

  • Prepare and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines.

  • Monitor the progress of the regulatory authority review process through appropriate communications with the agency.

  • Communicate and interacts with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools.

What you need

  • A minimum of Bachelor’s Degree is required.

  • A minimum of 3 years of experience in a FDA regulated industry required; preferably within medical devices.

  • A minimum of 2 years of Regulatory Affairs and Quality experience required or a combination of both.

  • RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred.

  • General understanding of product development process and design control.

  • Understanding of FDA and international medical device regulations.

  • Previous experience drafting 510(k)s preferred.

  • Experience interacting with regulatory agencies preferred.

  • 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.

  • Excellent interpersonal, written and oral communication skills.

  • Effective organizational skills.

  • Advanced PC skills with proficiency in Microsoft office Suite, including Excel.

Work From Home: Occasional

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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