Staff Specialist, Post Market Quality

Are you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker's RA/QA team, that is exactly what you will do! Here, we provide our RA/QA team the opportunity to learn new things, as well as endless growth opportunities! If you are interested in working at one of the World’s Best Workplaces, apply now !

Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs/Quality Assurance team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-regulatory-affairs-team

Ensures quality and regulatory compliance by completing the appropriate documentation and filings pertaining to complaints, incidents of injury, and recalls (product field actions – field corrections) as required by regulatory agencies. Responsible for performing activities associated with complaint file investigations, evaluations, and recalls through record closure, including inputs from manufacturing, engineering, suppliers, change control, risk management, and other departments as needed.

Key Areas of Responsibility:

• Develops and implements processes involved with maintaining annual licenses, registrations, and listings
• Reviews and approves advertising and promotion to ensure regulatory compliance
• Assures post-market regulatory requirements are met (e.g. required reports, supplemental submissions and other post-marketing commitments)
• Submits notifiable changes and supplemental dossiers to the appropriate regulatory authorities to update product information and/or instructions for use to reflect current state of product knowledge
• Participates in implementation of regulatory strategy and processes for handling recalls and communication to stakeholders (e.g. HCP, patient, distributor, and health authorities)
• Reports product safety issues to regulatory authorities as required, to comply with local, regional, and global regulations
• Provides required information in support of product reimbursement requests
• Provides regulatory input and appropriate follow-up for inspections and audits
• Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies
• Evaluates the regulatory environment and contributes to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance
• Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions
• Identifies requirements and potential obstacles for market access distribution (federal, provincial/territorial state, reimbursement, purchasing groups, etc.)
• Assists in the development of regulatory strategy and updates strategy based upon regulatory changes
• Evaluates proposed products for regulatory classification and jurisdiction
• Determines requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities
• Provides regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization
• Compares regulatory outcomes with initial product concepts and recommends changes or refinements based on initial regulatory outcomes
• Negotiates with regulatory authorities throughout the product lifecycle
• Identifies 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
• Assists other departments in the development of SOPs to ensure regulatory compliance

Education / Work Experience:

• BS in Engineering, Science, or related degree; or MS in Regulatory Science
• Typically a minimum of 5 years relevant experience
• Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), Regulatory Affairs Certification (RAC), and/or advanced degree in related field preferred.

Knowledge / Competencies:

• Strong project management, writing, coordination, and execution of regulatory items
• Emphasis on technical and scientific regulatory activities
• Demonstrate knowledge and skills in areas such as regulatory pathways, risk-benefit analysis, communication and collaboration internally and externally, submission, registration, obtaining approval, documentation, compliance, post-marketing surveillance/vigilance and distribution
• Under general supervision, plans, conducts and supervises assignments
• Reviews progress and evaluates results
• Recommends changes in procedures
• Operates with appreciable latitude for unreviewed action or decision
• Reviews progress with management
• May direct work of Specialist or Sr. Specialist
• Seeks out diverse ideas, opinion, and insights and applies them in the workplace
• Connects and relates well with people who think and act differently than oneself
• Embraces scrutiny and accepts feedback as opportunity to learn and improve
• Chooses the best alternative to achieve desired outcome or effect, giving consideration to risks, tradeoffs, timing, and available resources
• Navigates the dynamics, alliances, and competing requirements of the organization or business
• Willingly accepts challenging assignments and new career opportunities that stretch and build capabilities

About Stryker
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at stryker.com.