Ce site utilise des cookies. Pour en savoir plus sur notre politique d'utilisation des cookies, cliquez Politique d'utilisation des cookies

Senior Regulatory Affairs Specialist - Greenwood Village, CO - Stryker Corporation

Date de publication : 3/21/2019

Résumé de l'offre

Description de l'offre

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 Regulatory Affairs Specialist to join our Sports Medicine division in Greenwood, CO.

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. 
  • Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations. 
  • 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. 

What you will do

As the Senior Regulatory Affairs Specialist, you will ensure regulatory compliance by completing thorough assessments and completing the appropriate submissions pertaining to product clearances/approvals by FDA, Notified Bodies, and other regulatory bodies.

  • Develop and apply basic knowledge and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures.
  • Project management, writing, coordination, and execution of regulatory items.
  • Completing technical and scientific regulatory assignments that are broad in nature.
  • Handle assignments broad in nature, requiring originality and ingenuity. 
  • Prepare complex submissions to gain global approvals for clinical research, export, and commercial distribution, such as: IDE, 510(k), PMA, Shonin, Design Dossier, Technical File, and Certificates to Foreign Government.
  • Understand, investigate and evaluate regulatory history/background of class, disease/therapeutic/diagnostic context to assess regulatory implications for approval,
  • Assist in the development of regulatory strategy and update strategy based upon regulatory changes.
  • Develop and maintain positive relationships with regulatory agencies through oral and written communications regarding regulatory agency meetings, pre-submissions strategies, potential regulatory pathways, compliance test requirements, clarification, and follow-up of submissions under review.
  • Advise responsible personnel on regulatory requirements for quality, preclinical and clinical data requirements for clinical study applications or marketing applications.
  • Assess the acceptability of quality, preclinical and clinical documentation for submission filing to comply with regulatory requirements for clinical trials, marketing applications and corporate goals, to secure submission approval.
  • Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies.
  • Coordinate and execute preapproval compliance activities.
  • Determine and communicate submission and approval requirements.
  • Identify issues early in the submission preparation process that could impact product launch
  • Participate in negotiations and interactions with regulatory authorities during the development and review process to ensure submission approval/clearance.
  • Monitor applications under regulatory review.
  • Determine trade issues to anticipate regulatory obstacles.
  • Provide regulatory input to product lifecycle planning.
  • Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions.
  • Evaluate regulatory impact on proposed products.
  • Provide input on and review protocol and reports for design verification and validation. 
  • Participate in risk-benefit analysis for regulatory compliance.
  • Participate in design reviews of products under development.
  • Responsible for product release approval.
  • Maintaining regulatory paper and electronic files.
  • Review of advertising and promotional items.
  • Review collateral material associated with new launches and ongoing product support.
  • Assist in SOP development and review.

What you need

  • A Bachelor’s Degree (B.S or B.A) in Engineering, Science or equivalent focus is required.
  • A minimum of 3 years of experience in a FDA regulated industry.
  • A minimum of 2 years of Regulatory Affairs experience.
  • RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred.
  • 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.
  • 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.

Work From Home: No

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.

Rejoindre notre réseau de talents

En rejoignant notre réseau de talents, vous optimisez votre recherche d’emploi et vos candidatures. Que vous décidiez de déposer votre candidature ou simplement d’enregistrer vos coordonnées, nous nous ferons un plaisir de rester en contact avec vous.

Rejoignez notre équipe