Stryker Sr. Staff Regulatory Affairs Specialist in Portage, Michigan

The Senior Staff Regulatory Specialist will be a key member of the Regulatory Affairs team supporting Stryker's Medical division in Kalamazoo, Michigan. This team member will: be engaged in regulatory strategy and operations through technical and management skills; emphasize technical and scientific regulatory activities, to include strong project management, writing, coordination, and execution of regulatory documentation and related activities; and demonstrate knowledge and 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.

  • Pre-Market responsibilities will include:

  • Developing regulatory strategy and communicating with responsible personnel on regulatory requirements for clinical studies and/or marketing applications, including evaluation of regulatory filing strategies and assessment of resulting documentation for compliance with regulatory and corporate requirements.

  • Coordinating and executing pre-approval compliance activities and the preparation, review, and submission of regulatory filings.

  • Monitoring changing regulations, developing and implementing plans for continued compliance.

  • Assisting in the development and implementation of systems and processes to maintain and enhance regulatory compliance.

  • Negotiating and interacting with regulatory authorities during the development and review process to ensure submission approval.

  • Participating in internal/external audits.

  • Conducting regulatory reviews and approval of engineering change orders, CAPA/nonconformance, and related project documentation.

  • Post-Market responsibilities will include:

  • Ensuring compliance with product post-marketing approval requirements.

  • Reviewing and approving advertising/promotional items, product labeling and product claims to ensure compliance with regulatory requirements.

  • Identifying product-associated problems and developing proposals for solutions.

  • Assisting in the development and implementation of systems and processes to maintain and enhance regulatory compliance.

  • Providing regulatory input to support compliant resolution of production issues.

  • Participating in internal/external audits.

  • Conducting regulatory review and approval of engineering change orders, CAPA/nonconformance, and related project documentation.

Education and special trainings:

  • Bachelor’s Degree: Liberal Arts, Science, Engineering or related field.

Other requirements:

  • MS and/or RAC desired.

  • 7 - 8 years' related experience.

  • Possesses and applies broad and advanced knowledge, skills/abilities, and understanding of legal and regulatory frameworks, requirements, legislation, processes, and procedures.

  • Competent with Microsoft Office (Outlook, Excel, Word, etc.)

Work From Home: No

Travel Percentage: None

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.

Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com