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 Senior Staff Regulatory Specialist to join our Endoscopy Division to be based remotely anywhere within the United States.
Who we want
- Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
- Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities.
- Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate.
- Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
- Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
What you will do
As the Senior Staff Regulatory Affairs Specialist, you will be responsible to develop and execute global regulatory strategy for new and/or modified medical devices including expanded indications for use, to gain approvals for both clinical investigations and commercial distribution. You will advise on product/project development teams on regulatory pathway option(s) and requirements. You will be responsible to prepare complex submissions and/or presentations to health authorities and for any related communications and you will develop and mentor other regulatory affairs professionals within the department.
- Develop and execute global regulatory strategy for new and/or modified medical devices including for expanded indications for use.
- Prepare complex regulatory submissions and/or presentations (i.e. pre-submissions, IDEs, 510(k)s, Technical Files, etc.) to regulatory bodies (i.e. FDA, Notified Bodies, etc.) and for any related communications.
- Opportunity to participate in regulatory due diligence.
- Lead business unit in revision and/or development of processes/ procedures for, and implementation of, new or revised regulatory requirements based on either changes in the business or regulatory requirements.
- Partner regularly with marketing, engineering, clinical and quality on project and product development teams
- Serve as a regulatory affairs representative to improve awareness, visibility and communication on regulatory requirements to support company goals and priorities
What you need
- A Bachelor’s Degree (B.S or B.A) in Engineering, Science or equivalent focus is required.
- A minimum of 7 years of experience in an FDA regulated industry required; preferably with medical devices.
- A minimum of 3 years of Medical Device Regulatory Affairs experience required.
- RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred.
- General understanding of product development process and design control.
- General understanding of regulations applicable to the conduct of clinical trials.
- Previous experience with Class II medical devices required.
- Experience interacting with regulatory agencies required.
- Strong leadership skills.
- Demonstrated success in management of global regulatory strategy and submission activities.
- Demonstrated applied knowledge of FDA and international medical device regulations/standards/directive (i.e. European Medical Device Regulations).
- Ability to understand and explain detailed regulatory requirements among different countries and comply with constantly changing regulatory requirements.
- Strong leadership skills.