This site uses cookies. To find out more, see our Cookies Policy

Director of Regulatory Affairs in Greenwood Village, CO at Stryker Corporation

Date Posted: 3/24/2019

Job Snapshot

Job Description

WHAT YOU WILL DO:

As part of the leadership team in this dynamic, double digit growth and high energy global business, you will provide the leadership, people management, and technical expertise for the premarket Regulatory Affairs team.  You will Interact with the business unit general manager and cross-functional leadership team to support the direction, strategy, and growth of the organization.  Responsible for new product development from an RA perspective.

  • Will serve as a leader within the business unit as part of the business unit leadership team.  Able to effectively communicate, interact, and navigate issues at the executive level.
  • Create long term regulatory strategy and identify team needs by understanding the industry and regulatory landscape in combination with the business priorities and goals.
  • Manage the business unit Regulatory Affairs team.  Hires, trains, supervises, mentors, motivates, and develops staff.  Conducts performance management.
  • Accountable for the regulatory strategy, deliverables, and results to support new product development both domestically and internationally.  Regulatory pathways may include 510(k)s, PMA(s), Combination Products, etc.  Products contain focus on software and cybersecurity.
  • Provide regulatory guidance to and interact with cross functional business partners including R&D, Marketing, Quality, Operations, Legal and Compliance.
  • Lead due diligence and acquisition integration activities from a Regulatory Perspective; provide RA oversight and leadership.
  • Effectively interact with other Regulatory leaders in the organization including international, post market, and premarket in other business units/divisions of Stryker.
  • Stay abreast of regulatory standards/guidances and communicate relevant information within the business.  Participate in industry events such as Advamed working groups or specialized meetings/forums related to the business unit products.
  • Lead external audits including direct interaction with FDA, ISO, and other external auditors.  Serve as lead during corporate internal audits.
  • Support Quality System activities including NC/CAPA, Internal Audit, and change control.

WHAT YOU WILL NEED:

  • 2-4 years as a Director of Regulatory Affairs function or equivalent experience. 10+ years of professional experience.
  • B.S. in engineering, engineering management, or related discipline.
  • Formal training in Regulatory Affairs.
  • Experience with successful 510(k) clearances.  Prefer additional experience with PMA(s) and/or combination products.
  • Must be able to communicate with large groups of people.
  • Must be able to review printed materials.
  • Must be able to routinely make decisions which affect immediate operations and may have a company-wide effect.

WHO WE WANT:

  • Sets direction. An innovator who defines ways to create value and deliver on Stryker’s mission and strategic imperatives.
  • Builds organizational capability. A strategic executive who continuously breaks down barriers, identifying new and more effective ways to accomplish tasks and goals.
  • Inspires others. A genuine, relationship-focused leader who connects, collaborates and fosters an inclusive environment of enthusiasm, trust and pride. He/she makes others want to follow, building momentum for action and positively influencing outcomes.
  • Champions talent development. A manager who focuses on maximizing the ability, potential and contributions of themselves and others. Fosters an environment where people can excel through developing, coaching and rewarding performance.
  • Delivers results. A driven player/coach who sets high goals for personal achievement and organizational success. He/she measures success against the best internal and external benchmarks.

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.

Join our talent network

Joining our talent network will enhance your job search and application process. Whether you choose to apply or just leave your information, we look forward to staying connected to you.

Join Our Team