Senior Regulatory Affairs Specialist in Portage, MI at Stryker Corporation

Date Posted: 9/25/2018

Job Snapshot

Job Description

The Senior Regulatory Affairs Specialist performs technical and scientific regulatory activities, to include project management, writing, coordination, and execution of regulatory documentation and related activities.

Pre-Market duties and responsibilities:

  • Advise 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.
  • 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 duties and responsibilities:

  • 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.
  • 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.

Education and special trainings:

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

  • MS and/or RAC preferred.

  • 2-3 years related experience.

Other requirements:

  • Developed and applied basic knowledge and understanding of the regulatory and legal framework, regulatory requirements, legislation, processes, and procedures.
  • Must thrive in a team environment, build strong relationships and demonstrate leadership capabilities.
  • Must have excellent interpersonal communication skills specially relating to people, conflict, and stress management.
  • Must have a passion for continuous improvement and demonstrated problem solving skills.
  • Must have a passion for quality and procedural compliance.
  • Must have excellent time management skills with the ability to use judgment effectively.
  • 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.

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