Staff Regulatory Affairs Specialist (Software) en Portage, MI a Stryker Corporation

Fecha de publicación: 10/13/2019

Resumen de la oferta

Descripción del empleo

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 Staff Regulatory Affairs Specialist to join our Medical Division to be located in Kalamazoo, Michigan.

Who we want

  • Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities. 
  • 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. 
  • Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
  • Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

What you will do

As a Staff Regulatory Affairs Specialist you will ensure regulatory compliance by completing thorough assessments and the appropriate submissions pertaining to product clearances/approvals by FDA, Notified Bodies, and other regulatory bodies. Focuses on products with software with other devices or external networks.

  • Pre-Market
    • Develop regulatory strategy and communicate with responsible personnel on regulatory requirements for clinical studies and/or marketing applications, evaluation of regulatory filing strategies, and assessment of resulting documentation for compliant with regulatory and corporate requirements.
    • Coordinate and execute pre-approval compliance activities and the preparation, review, and submission of regulatory filings.
    • Monitor impact of changing regulations, develop and implement plans for continued compliance.
    • Assist in the development and implementation of systems and processes in order to maintain and enhance regulatory compliance.
    • Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval.
    • Participate in internal/external audits.
    • Conduct regulatory review and approval of engineering change orders, CAPA/nonconformance, and related project documentation.
  • Post-Market
    • Ensure compliance with product post-marketing approval requirements.
    • Review and approve advertising/promotional items, product labeling, and product claims to ensure compliance with regulatory requirements.
    • Identify product-associated problems and develop proposals for solutions.
    • Assist in the development and implementation of systems and processes in order to maintain and enhance regulatory compliance.
    • Provide regulatory input to support compliant resolution of production issues.
    • Participate in internal/external audits.
    • Conduct regulatory review and approval of engineering change orders, CAPA/nonconformance, and related project documentation.

What you need

  • Bachelor’s degree in Engineering, Biological Sciences or equivalent scientific area preferred
  • 5+ years of Regulatory Affairs experience with 3+ years in an FDA regulated industry
  • 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 may also have

  • Software-related regulatory experience (eg. IEC62304, FDA Software/Cybersecurity Guidance documents, SaMD, Medical Mobile Apps, Cloud based solutions, privacy, PII, PHI)
  • Regulatory Affairs Certification (RAC) or advanced degree (Masters in Regulatory Affairs)

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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