Regulatory Affairs Manager in Shirley, MA at Stryker Corporation

Date Posted: 1/17/2020

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 Regulatory Affairs Manager to join our team based in Shirley, Massachusetts.

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 a Regulatory Affairs Manager, you’ll be responsible for developing, implementing and maintaining Quality Assurance systems and activities within FDA regulatory guidelines. You’ll ensure regulatory compliance by completing the appropriate filings and documentation pertaining to incidents of injury, recall, product approval and product registration as required by regulatory agencies.

Essential Duties & Responsibilities

  • Defines, specifies, and/or approves of the implementation of standards, methods, and procedures for inspecting, testing, and evaluating the precision, accuracy and reliability of company products.
  • Oversees departmental participation in the reviewing of engineering designs to assure consideration for and compliance to Quality Assurance requirements and considerations.
  • Involved in developing, modifying, and executing regulatory related company guidelines and procedures.
  • Responsible for failure analysis associated with the complaint management system, including documentation of failures, cause of failures, and identification of corrective actions.
  • Will train others on QA topics
  • Assists vendors in establishing inspection standards to meet the company’s quality requirements.
  • Will conduct internal Quality Assurance compliance audits and communicate results.
  • Will interface with external auditing entities and communicate results.
  • Assures that the requirements of ISO9001, EN29001, EN46001, and any other applicable government or international standards are implemented and maintained.
  • Ensure MDR investigations and filings, communication of complaint investigation to Sales Rep/Customers, internal regulatory and quality audits, complaint trend analysis are completed and evaluated in accordance with regulatory requirements.
  • May manage directly and/or through subordinate supervisors the activities of the Quality Assurance and Regulatory Affairs department and the Document Control Group.
  • Sets overall departmental goals and priorities and evaluates subordinate’s performance against those goals and priorities.
  • Coaches and develops direct reports
  • Responsible for inter-departmental compliance with company policies and corrective actions.

What you need

  • Bachelors degree in a science, engineering or related; Advanced degree or RAC preferred
  • 9+ years of experience in an FDA regulated industry
  • Intermediate understanding of procedures for the QA/RA functions to departmental and non-departmental personnel 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.

Work From Home: Occasional

Travel Percentage: 10%

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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