Principal Engineer-Regulatory Affairs Specialist
Stryker
- Bangalore, Karnataka
- Permanent
- Full-time
Hard-working winners. Confident, competitive and results-oriented professionals who create a track record of success.
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.
Effective communicators. People who can interpret information clearly and accurately to concisely communicate results and recommendations to stakeholders.
Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.Position Summary:This position will be responsible for possessing and applying broad and advanced knowledge, setting direction and regulatory strategy, skills/abilities and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures. Responsible for Leading team of Regulatory professionals to ensure regulatory compliance by driving implementation of selected regulatory requirements at the local, state, or federal/regulatory agency levels. Responsible for developing talent within team to increase performance.
Supporting new product development for both domestic and international release by contributing to the development and updating of regulatory strategy based upon regulatory changes. Supporting the product lifecycle through obsolescence by assessing changes made to the device post launch to determine regulatory impact of changes to the current clearance. Ensuring regulatory compliance by completing thorough assessments and completing the appropriate submissions pertaining to product clearances/approvals by FDA, Notified Bodies, and other regulatory bodies. Serves as a divisional resourceWhat you will doGeneral Responsibilities:· Assesses links between global, societal and economic trends; stakeholder concerns and regulatory issues and requirements; and the implications for regulatory strategy. Participates in advocacy activities of a more advanced strategic nature· Develops and updates global, regional and multi-country regulatory strategy, and aligns regulatory strategies to organizational strategies· Provides guidance to integrate regulatory considerations into global product entry and exit strategy· Works with little to no supervision or instruction. Expected to take on leadership role on significant projects. Acts as divisional technical mentor / lead of others in department. Demonstrates advanced technical leadership skills and influence outside of department· Makes informed decisions based on business frameworks and tools and give consideration to risks tradeoffs, timing, and available resources· Identifies regulatory pathways for initial product designs and provides input to internal stakeholders· Analyzes the adequacy of proposed regulatory pathways and strategy for initial product designs and recommends changes or refinements based on initial regulatory outcomes· Assesses all requirements and potential obstacles for market access and distribution (federal, provincial/territorial/state, reimbursement, purchasing groups, etc.) and develops solutions to address anticipated obstacles· Critically assesses the impact of changing regulations on preapproval and post approval strategies and approaches based on changing regulations· Provides in-depth understanding and ability to incorporate regulatory strategies to expedite development for products intended for serious or life-threatening medical conditions or that address unmet medical needs (e.g. orphan, conditional approval, breakthrough therapy)· Negotiates with regulatory authorities on complex issues throughout the product lifecycle· Establishes working relationships and interfaces with multiple government and non-government organizations having an impact on market access and distribution· Identifies the need for and manages the development and execution of new regulatory procedures and standard operating procedures· Develops and manages programs that train stakeholders on current and new regulatory requirements to ensure organization-wide compliance· Provides strategic input and technical guidance on global regulatory requirements to product development terms· Evaluates risks of product and clinical safety issues during clinical phases and recommends regulatory solutions· Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans for changes that do not require submissions· Reviews and assesses proposals to regulatory authorities on regulatory paths and clinical plans· Monitors implementation of regulatory strategies relative to product and clinical safety issues identified during clinical phases· Provides knowledge and critical analysis of preapproval inspections, GCP inspections and clinical investigator relationships· Provides regulatory guidance on strategy for proposed product claims/labeling· Ensures clinical and nonclinical data are consistent with the regulatory requirements and support the proposed product claims· Manages electronic (eCTD) and paper registration development· Ensures policies and procedures are in place for appropriate internal review and approval of regulatory submissions· Leads key negotiations and interactions with regulatory authorities during all stages of the development and review process· Prepares cross-functional teams for interactions with regulatory authorities including panel/advisory committeesTasks may include:· Consistently managing simple and complex projects· Leading SOP development and review· Leading the development and update of regulatory strategy based upon regulatory changes· Providing regulatory strategy and input to new product development and product lifecycle planning· Mentoring junior staff members· Evaluating regulatory impact of proposed changes to launched products· Demonstrating understanding and ability to investigate and evaluate regulatory history/background of class, disease/therapeutic/diagnostic context in the assessment of regulatory implications· Determining and communicating submission and approval requirements· Participating in risk-benefit analysis for regulatory compliance· Continuing to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actionsAdditional tasks may include:· Maintaining annual licenses, registrations, and listings· Reviewing regulatory aspects of contracts· Ensuring compliance with product post-approval or clearance requirements· Approving labeling, advertising and promotional items for compliance before release· Reviewing publicly disseminated information to minimize regulatory exposure· Reviewing product claims and preserving confidentiality of applicable product information· Providing regulatory input for and appropriate follow-up to inspections and audits· Assisting in the development and implementation of SOPs and systems to track and manage product-associated events· Reviewing change management to determine the level of change and potential submission requirements· Identifying product-associated problems and developing proposals for solutions· Advising responsible personnel on regulatory requirements for quality, preclinical and clinical data requirements for clinical study applications or marketing applications· Evaluating proposed preclinical, clinical and manufacturing changes for regulatory filing strategies· Assessing the acceptability of quality, preclinical and clinical documentation for submission to comply with regulatory requirements· Monitoring impact of changing regulations on submission strategies· Identifying issues early in the submission preparation process that could impact product launch· Compiling, preparing, reviewing and submitting regulatory dossiers to authorities· Participating in negotiations and interactions with regulatory authorities during the development and review process to ensure submission approval/clearance·What you need:·
- B.A. or B.S.in Science, Legal, Regulatory or Engineering, or equivalent
- RAC certification preferred.
- Advanced Certifications or Development Expected
- Industry Working Group/Committee Participation Desired
- 9+ year’s experience
- Technical and management skills and engaged in regulatory strategy and operations.
- 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-market 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
- Minimum of 9 years of regulatory experience in the medical device or pharmaceutical industry