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Senior Regulatory Affairs Specialist

Stryker Virtual, Arkansas Full-Time
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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

The Senior Regulatory Affairs Specialist works to bring medical devices to market and ensures ongoing compliance. Participates on cross-functional teams, develops global regulatory strategies, authors regulatory submissions, interacts with regulatory agencies/notified bodies, reviews labeling and marketing materials, and evaluates proposed device changes.

Responsibilities:

  • Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies  
  • Participates in advocacy activities of a more advanced technical and/or tactical or strategic  nature  
  • Evaluates the regulatory environment and contributes to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance
  • Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions
  • Identifies requirements and potential obstacles for market access distribution (federal, provincial/territorial state, reimbursement, purchasing groups, etc.)
  • Assists in the development of regulatory strategy and updates strategy based upon regulatory changes
  • Evaluates proposed products for regulatory classification and jurisdiction
  • Determines requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities
  • Provides regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization
  • Compares regulatory outcomes with initial product concepts and recommends changes or refinements based on initial regulatory outcomes
  • Negotiates with regulatory authorities throughout the product lifecycle
  • Identifies the need for new regulatory procedures, SOPs, and participates in development and implementation
  • Helps train stakeholders on current and new regulatory requirements to ensure organization-wide compliance
  • Assists other departments in the development of SOPs to ensure regulatory compliance
  • Provides regulatory input and technical guidance on global regulatory requirements to product development teams
  • Advises stakeholders of regulatory requirements for quality, pre-clinical, and clinical data to meet applicable regulations
  • Assesses the acceptability of quality, pre-clinical, and clinical document for submission filing to comply with applicable regulations
  • Evaluates proposed pre-clinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissions
  • Provides knowledge and guidance on pre-approval inspections, GCP inspections, and clinical investigator relationships
  • Identifies, monitors, and submits applicable reports or notifications to regulatory authorities during the clinical research process
  • Provides regulatory information and guidance for proposed product claims/labeling
  • Ensures that the clinical and nonclinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims
  • Prepares and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines
  • Monitors the progress of the regulatory authority review process through appropriate communications with the agency
  • Communicates and interacts with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools
  • Works with cross-functional teams for interactions with regulatory authorities including panel meetings and advisory committees

What you need

  • Bachelor’s degree required with Engineering, Biological Sciences or equivalent focus preferred
  • 3+ 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 might also have

  • Experience working in an FDA regulated industry
  • Previous experience with Class II/III medical devices
  • Experience drafting 510(k)s
  • RAC certification or advanced degree (Masters in Regulatory Affairs)

Work From Home: Yes

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.
 

Skills required

Administration
Ensure Compliance
Provide Direction
Provide Actionable Feedback
Prepare Regulatory Submission
Provide Regulatory Support
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Job ID: R417919

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