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Regulatory Specialist, Post Market Surveillance

2 months ago

Leesburg, United States Stryker Full time

Work Flexibility: Remote

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at www.stryker.com

Who we want

  • Business-oriented evaluators. People who effectively interpret information to demonstrate the effects of business initiatives, regulation and industry trends for sales, management and leadership teams.
  • 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.
We are currently seeking a Regulatory Affairs Specialist, Post Market Surveillance to join our Spine Division. This role will be based remotely anywhere in the United States.

What you will do

This position will be responsible for creating clear, accurate, and regulatory-compliant documentation related to post market surveillance compliance for the Stryker Spine Division (euMDR, ISO, FDA, Intl markets). The person will develop basic knowledge and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes, and procedures.
  • Implements processes involved with maintaining annual licenses, registrations, and listings.
  • Assures post market regulatory requirements are met (e.g. required reports, other post marketing commitments)
  • Provides regulatory input and appropriate follow-up for inspections and audits.
  • Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies.
  • 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 implements solutions.
  • Assists in the development of regulatory strategy and updates strategy based upon regulatory changes
  • Contributes to development and implementation of new regulatory procedures and SOPs.
  • Responsible for writing and maintaining post market surveillance plans and reports (Post Market Surveillance Report / Periodic Safety Update Reports) according to regulations (EU) 2017/745, MDD guideline 92/42 / EEC, ISO 13485, FDA, etc.
  • Responsible for actively monitoring product performance (collection, evaluation and analysis of complaint data, adverse events, recalls, feedback, etc.)
  • Use of dashboards/ data visualization using Power BI tools that support different initiatives on the post market surveillance teams.
  • Work cross-functionally with various departments (medical affairs, research and development, risk management, clinical affairs) to ensure PMS processes are adequately implemented.
What you need
  • Bachelor's Degree Required. Bachelor's degree in engineering or science preferred.
  • 0 - 2 years related work experience in an FDA or regulated industry is a plus.
  • 1+ years medical device or regulatory experience - preferred.
  • Related work experience in an FDA or regulated industry is a plus.
  • 1+ years medical device or regulatory experience - preferred.
  • Knowledge of FDA and international medical device regulations and standards (CFR, MDR, QSR, ISO 13485, MDSAP, etc.)- preferred
  • Medical device product experience preferred.
  • Familiarity with BI tools and software coding (Power BI, Tableau, R/ Python/SQL) preferred.
  • Ability to understand regulatory requirements and translate into dashboards/ data visualization/ BI tools/ trending.
  • Familiar with statistical concepts and trending
  • Adaptable to a fast-paced environment with changing circumstances, direction and strategy and has the desire to thrive in a dynamically thriving environment
  • Detailed-oriented- committed to accuracy, efficiency, and consistency
  • Ablity to work independently or with a team
  • Strong interpersonal, written, and oral communication skills
  • Problem solver and innovator
  • Good time and project management skills with the ability to multi-task
  • Spinal/Orthopedic product knowledge desirable


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.