About Stryker
Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine. Learn more about our award-winning organization by visiting stryker.com
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 Staff Regulatory Specialist to join our Medical Division to be... based in Portage, MI or remotely within Michigan, Indiana, Ohio, Illinois or Wisconsin.
Who we want
- Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate.
- Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities.
- 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
We are looking for a collaborative team player who is interested in bringing and sustaining products on the market via pre-market submission activities with global Health Authorities. Operating in a fast paced environment, the Staff Regulatory Affairs Specialist will liaise with internal and external customers and establish strong relationships with Health Authorities in Europe, Japan, Canada and other International countries. You are responsible global product environmental compliance and labelling process. You are able to translate complex engineering or scientific principles into approachable content while educating others on Stryker products and processes. You are self-directed and motivated to act while taking on projects of greater complexity under limited supervision.
- Assess regulatory intelligence to assist in the development of local, regional, and global regulatory strategies.
- Evaluate the regulatory environment and contributes to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance.
- Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions.
- Assist in the development of regulatory strategy and updates strategy based upon regulatory changes.
- Determine requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities.
- Provide regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization.
- Negotiate with regulatory authorities throughout the product lifecycle.
- Advise stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations.
- Prepare and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines.
- Communicate and interacts with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools.
- Work with cross-functional teams for interactions with regulatory authorities including panel meetings and advisory committees.
What you need
- A Bachelor’s Degree (B.S or B.A) in Engineering, Science or equivalent focus is required.
- A minimum of 5 years of experience in a regulated industry required; preferably with medical devices.
- A minimum of 4 years of Medical Device Quality experience or 2 years of Regulatory Affairs experience required.
- RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred.
- General understanding of product development process and design control.
- Thorough understanding of FDA and international medical device regulations required.
- Experience with medical device 510(k) preferred.
- Previous experience drafting regulatory submissions preferred.
- Experience interacting with regulatory agencies preferred.
- 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.
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