Senior Regulatory Affairs Specialist (Remote)

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Posted 3 days ago United States Salary undisclosed
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Job Description

Work Flexibility: Remote or Hybrid or Onsite

We are currently seeking a Senior Regulatory Specialist to join our Medical Division to be based in Portage, MI or remotely within any state located within the Central Standard Time Zone or the Eastern Standard Time Zone.

Who we want
  • 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.
  • 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 the coordination and preparation of change assessments and document packages for regulatory submissions in the United States. You will be a collaborative team player who is interested in bringing and sustaining products on the market via pre-market submission activities with global Health Authorities. You will liaise with internal and external customers and establish strong relationships with the FDA. You are responsible global product field action process. You will translate complex engineering or scientific principles into approachable content while educating others on Stryker products and processes. You will be motivated to act while taking on projects of greater complexity under limited supervision.
  • Assess regulatory intelligence to assist in the development of local, regional, and global regulatory strategies.
  • 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.
  • Evaluate proposed products for regulatory classification and jurisdiction.
  • 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.
  • Provide regulatory input and technical guidance on global regulatory requirements to product development teams.
  • Advise stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations.
  • Assess the acceptability of quality, preclinical, and clinical document for submission filing to comply with applicable regulations.
  • Evaluate proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and propose plans/strategizes (if appropriate) for changes that do not require submissions.
  • 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.
  • Work with cross-functional teams for interactions with regulatory authorities including panel meetings and advisory committees.

What you need
  • A Bachelor's Degree (B.S or B.A) required; preferably in Engineering, Science or equivalent focus.
  • A minimum of 3 years of experience in an FDA or highly regulated industry required.
  • A minimum of 1 year in a Regulatory Affairs role preferred.
  • RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred.
  • General understanding of product development process and design control preferred.
  • General understanding of regulations applicable to the conduct of clinical trials preferred.
  • Previous experience with US Class II/III medical devices 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.

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.