Senior Principal Regulatory Affairs Specialist en Redmond, WA a Stryker Corporation

Fecha de publicación: 9/28/2019

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 Senior Principal Regulatory Affairs Specialist to join our Medical Division to be based in Redmond, WA.

Who we want

  • Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate. 
  • 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. 
  • Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations. 
  • 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.

What you will do

As the Senior Principal Regulatory Affairs Specialist, you will engage in regulatory strategy and operations through technical and management skills. You will engage in technical and scientific regulatory activities, to include strong project management, writing, coordination, and execution of regulatory documentation and related activities. You will utilize skills in areas such as: regulatory pathways, risk-benefit analysis, internal/external communication and collaboration, submission, registration, obtaining approval, documentation, compliance, post-market surveillance/vigilance, and/or distribution.

  • 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.
  • May manage other employees or contractors within the regulatory team.

  • Oversee the training, development and activities of less experienced regulatory specialists.

  • 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.
  • 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

  • A minimum of a Bachelor’s Degree (B.S. or B.A.) in Science, Engineering, Legal, or Regulatory or related​ discipline required.
  • A minimum of 12 years of experience in an FDA regulated industry required.
  • A minimum of 5 years in a Medical Device Regulatory Affairs role required.
  • RAC certification or Advance Degree (Master in Regulatory Affairs) preferred​.
  • Competent with Microsoft Office (Outlook, Excel, Word, etc.).
  • Must possess excellent oral and written communication skills.
  • Must thrive in a team environment, build strong relationships and demonstrate leadership capabilities.
  • Excellent interpersonal communication skills specially relating to people, conflict, and stress management.
  • A passion for continuous improvement and demonstrated problem solving skills.
  • A passion for quality and procedural compliance.
  • Excellent time management skills with the ability to use judgment effectively.
  • Previous experience supporting submissions to the FDA.
  • Ability to understand and explain detailed regulatory compliance programs and/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 judgment.
  • Ability to communicate and network with regulatory personnel to obtain relevant information.
  • Ability to negotiate internally and externally with FDA.
  • Excellent analytical and writing skills.

Work From Home: Not available

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.

Únase a nuestra red de talentos

Si se une a nuestra red de talentos, mejorará el proceso de búsqueda y solicitud de empleo. Tanto si desea solicitar un trabajo como si solo quiere dejarnos sus datos, deseamos mantener el contacto con usted.

Únase a nuestro equipo