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Senior RA Specialist in Portage, MI at Stryker Corporation

Date Posted: 1/13/2019

Job Snapshot

Job Description

Senior Regulatory Affairs Specialist

Do you have a passion and a drive for regulatory and quality? Are you looking to be part of a motivated, highly visible team with a leader in the medical technology industry? Becoming a Regulatory Affairs Specialist at Stryker CMF will give you just that. The Senior Regulatory Affairs Specialist is a critical link with Stryker, its products, end users, and Regulatory Authorities and has a direct impact on product availability, customer satisfaction and customer safety. The Senior Specialist combines their knowledge of scientific, regulatory, legal frameworks, legislation and business practices to ensure Stryker is in compliance with the current regulations surrounding reporting, marketing, labeling, and legal issues in order to control the safety and efficacy of our products. 

Crucial to this position is the art of building relationships with diverse functional groups including manufacturing sites, sales representatives, device end users, fellow Regulatory and Quality System colleagues, and regulators. The best candidates will also possess strong analytical and problem-solving skills along with strong communication skills, a keen understanding of a highly regulated environment, great attention to detail and the ability to make important decisions independently.

In this role, you may:

  • Prepare, review, analyze, and file appropriate regulatory documentation (510k’s, FDA registration and listings, etc.).
  • Perform MDR investigations and filings.
  • Coordinate, recall, review, and complete associated documentation.
  • Provide regulatory compliance guidance and/or training to others; interact with customers to resolve issues.
  • Communicate and/or facilitate communication of complaint investigation results to sales reps/ customers.
  • Review complaints for adequate closure.
  • Represent the Quality function in the management review process by covering customer complaints, MDR trending, post market surveillance, CAPA and the quality policy per the quality documents.
  • Review labeling and literature for regulatory compliance.
  • Assist customers in resolving product issues through complaint investigation/ problem solving, customer training, design improvements, and special orders.

Education Required:

  • Bachelor’s degree (Life Sciences, Engineering, Computer Science or Business preferred).

Qualifications/ Work Experience:

  • 2+ years of regulatory experience (Medical Device, Biologics or Pharmaceutical industry experience preferred).
  • MS or RAC Certification preferred.
  • Excellent interpersonal, written and oral communication skills.
  • Strong collaboration skills.
  • Excellent analytical skills, including ability to prioritize and resolve non-routine product issues using independent judgment.
  • Ability to understand and explain detailed regulatory compliance programs and/or issues.
  • Effective 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.

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