Manager Regulatory Affairs in Virtual, Minnesota at Stryker Corporation

Date Posted: 10/2/2019

Job Snapshot

Job Description

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 Manager Regulatory Affairs to join our ENT Division to be based in Plymouth, MN.

Who we want

  • Managers who drive performance. People who implement process improvements and leverage the talent of their team to consistently increase performance and productivity.
  • Goal-oriented orchestrators. People who can effectively coordinate and focus the work of skilled employees toward an important goal, prioritizing to the right activities that lead to success.   
  • Accuracy-oriented team leaders. Providing direct oversight of processes and results, managers who ensure accurate and timely completion of projections, forecasts or reporting.
  • Subject matter experts. Managers who not only oversee the collection, review, and analysis of data but can interpret, translate, and present on all various matters as needed.

What you will do

As the Manager Regulatory Affairs, you will be responsible for overseeing activities associated with worldwide regulatory affairs and other activities to support the Vice President of Clinical, Regulatory and Quality.  You will have supervisory responsibility for Regulatory Affairs Associates in the department.

  • Support the VP of Regulatory Affairs in developing a partnership with other departments in designing and enhancing regulatory initiatives to facilitate overall regulatory compliance.
  • Ensure regulatory goals and objectives, annual operating plans and budgets are aligned with corporate goals and that priorities are maintained.
  • Manage the activities of, develops, and coaches’ regulatory affairs personnel.
  • Participate in and supports product development teams for new and continuing projects.
  • Review documentation, protocols and reports received and prepares additional written materials as needed.
  • Prepare and review US and OUS regulatory submissions required for approval or registrations, including 510(k)s, IDEs, PMAs, INDs, NDAs, Memos to 510(k) files, Technical Files, Medical Device Reports, and other regulatory submissions as applicable.
  • Prepare and review responses to FDA letters, supplements, and amendments; and participates in FDA inspections and presentations as needed.
  • Review and approve product & process changes and labeling materials according to regulations.
  • Write Standard Operating Procedures (SOPs) as needed to comply with the regulations.
  • Prepare and submits post-market MDRs and Vigilance reports as required.
  • Keep apprised of new regulations, standards, policies, and guidance issued by relevant regulatory authorities that may impact the company.

What you need

  • A minimum of a Bachelor’s Degree (B.S. or B.A.) degree required.
  • A minimum of 9 years of experience in a FDA regulated industry required.
  • A minimum of 5 years in a Medical Device Regulatory Affairs role required; including worldwide regulatory experience and knowledge.
  • A minimum of 1 year of previous management experience required.
  • RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred.
  • Experience authoring regulatory submissions for product approval and interacting with regulatory agencies required.
  • Proven ability to develop, author and implement global regulatory strategies for new products required.
  • Ability to manage regulatory personal effectively.
  • Ability to comprehend principles of engineering, physiology and medical device use.
  • Excellent understanding of FDA Regulations, International ISO Standards, European Medical Device Directive (MDD), EU Medical Device Regulation (MDR), Canadian Medical Device Regulations and other OUS regulations.
  • 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: 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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