SeniorFull TimeEN
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 Senior Regulatory Affairs Specialist to join our Trauma & Extremities Division to be based in Switzerland.
Who we want
Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
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.
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.
Goal-oriented developers. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.
What you will do
The Senior Regulatory Affairs Specialist you will work to bring medical devices to market and ensures ongoing compliance. You will participate on cross-functional teams, develop global regulatory strategies, author regulatory submissions, interacts with regulatory agencies/notified bodies, review labeling and marketing materials, and evaluates proposed device changes.
Assess regulatory intelligence to assist in the development of local, regional, and global regulatory strategies.
Participate in advocacy activities of a more advanced technical and/or tactical or strategic nature.
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.
Identify requirements and potential obstacles for market access distribution (federal, provincial/territorial state, reimbursement, purchasing groups, etc.).
Assist in the development of regulatory strategy and updates strategy based upon regulatory changes.
Evaluate proposed products for regulatory classification and jurisdiction.
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.
Compare regulatory outcomes with initial product concepts and recommends changes or refinements based on initial regulatory outcomes.
Negotiate with regulatory authorities throughout the product lifecycle.
Identify the need for new regulatory procedures, SOPs, and participates in development and implementation.
Helps train stakeholders on current and new regulatory requirements to ensure organization-wide compliance.
Assist other departments in the development of SOPs to ensure regulatory compliance.
Provide regulatory input and technical guidance on global regulatory requirements to product development teams.
Advise stakeholders of regulatory requirements for quality, pre-clinical, and clinical data to meet applicable regulations.
Assess the acceptability of quality, pre-clinical, and clinical document for submission filing to comply with applicable regulations.
Evaluate proposed pre-clinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissions.
Provide knowledge and guidance on pre-approval inspections, GCP inspections, and clinical investigator relationships.
Identify, monitor and submit applicable reports or notifications to regulatory authorities during the clinical research process.
Provides regulatory information and guidance for proposed product claims/labeling.
Ensures that the clinical and nonclinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims.
Prepares and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines.
Monitors the progress of the regulatory authority review process through appropriate communications with the agency.
Communicates and interacts with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools
Works with cross-functional teams for interactions with regulatory authorities including panel meetings and advisory committees.
What you need
A minimum of a Bachelor’s Degree (B.S. or B.A.) in Science, Engineering or equivalent focus required.
A minimum of 3 years of experience in an FDA or highly regulated industry required.
A minimum of 1 year in a Regulatory Affairs role required.
Previous experience with Class II/III medical devices preferred.
Previous experience drafting 510(k)s preferred.
RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred.
Experience authoring regulatory submissions for product approval 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.
Travel Percentage: None
