Senior Staff Regulatory Affairs Specialist in Plymouth, MN at Stryker Corporation

发布日期: 8/23/2019



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 Staff Regulatory Affairs Specialist to join our ENT Division in Plymouth, MN.

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.
  • 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. 
  • 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 Staff Regulatory Affairs Specialist, you will support new and legacy products for both US and OUS Global Regulatory release by contributing to the development and updating of regulatory strategy based upon regulatory changes. Prepare US and OUS regulatory submissions required for approval or registrations, including 510(k)s, IDEs, PMAs, Memos to 510(k) files, Technical Files, Design Dossier, and other regulatory fillings.

  • Support the Manager of Regulatory in developing a partnership with other departments in designing and enhancing regulatory initiatives to facilitate overall regulatory compliance.
  • Prepare responses to FDA letters, supplements, and amendments.
  • Review and approve product & process changes and labeling materials according to regulations.
  • Write Standard Operating Procedures (SOPs) as needed to comply with the regulations.
  • Keep apprised and have a strong understanding of new or changing regulations, standards, policies, and guidance issued by relevant regulatory authorities that may impact the company.
  • Assist in the review of documentation, protocols and reports received; and prepares additional written materials as needed.
  • Demonstrates strong project management, writing, coordination, and execution of regulatory items, with emphasis on technical and scientific regulatory activities.
  • Demonstrates knowledge and skills in areas of regulatory pathways, risk-benefit analysis, communication and collaboration internally and external, submission, registration, obtaining approval/clearance, documentation, post marketing compliance.
  • Reports observations/ problems clearly and concisely and takes appropriate actions.
  • Demonstrates developing of advanced technical leadership skills within the department.
  • Possesses and applies a broad knowledge and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures.
  • Demonstrates strong project management, writing, coordination, and execution of regulatory items, with emphasis on technical and scientific regulatory activities.

What you need:

  • A Bachelor’s degree in Engineering, Biological Sciences or equivalent focus required.
  • A minimum of 7 years of working in a FDA regulated industry required.
  • A minimum of 2 years of Regulatory Affairs experience required.
  • Previous experience with Class II / III Medical Devices preferred.
  • 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.