Senior Regulatory Affairs Specialist

JOB DESCRIPTION: Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to: Career development with an international company where you can grow the career you dream of Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. An excellent retirement savings plan with high employer contribution Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists For years, Abbott’s medical devicebusinesses have offered technologies that are faster, more effective, and less invasive. Whether it’s glucose monitoring system, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks. THE OPPORTUNITY As an individual contributor, the function of a Senior Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment. The individual may execute tasks and play a consultative role by partnering across business functions. The individual may assist in identifying data needed, obtaining these data and ensuring that they are effectively presented for the registration of products worldwide. The individual may prepare and submit documentation needed for registration worldwide or may oversee such preparation. MAIN RESPONSIBILITIES Strategic Planning: Assist in SOP development and review. Provide regulatory input to product lifecycle planning. Continue to revisit and compare regulatory outcomes with initia l product concepts to make recommendations on future actions. Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes. Understand, investigate and evaluate regulatory history/background of class, disease/ therapeutic/diagnostic context in order to assess regulatory implications for approval. Determine trade issues to anticipate regulatory obstacles. Determine and communicate submission and approval requirements. Participate in risk-benefit analysis for regulatory compliance. Premarket: Assess the acceptability of quality, preclinical and clinical documentation for submission filing. Compile, prepare, review and submit regulatory submission to authorities. Monitor: Impact of changing regulations on submission strategies. Monitor applications under regulatory review. Monitor and submit applicable reports to regulatory authorities. Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies. Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval is important. Post market: Maintain annual licenses, registrations, listings and patent information. Assist compliance with product post marketing approval requirements. Review and approve advertising and promotional items to ensure regulatory compliance. Assess external communications relative to regulations. Review of regulatory aspects of contracts. Assist with label development and review for compliance before release. Submit and review change controls to determine the level of change and consequent submission requirements. Analyze the input of cumulative product changes to current product submissions. Contribute to the development and functioning of the crisis / issue management program. Ensure product safety issues and product-associated events are reported to regulatory agencies. Provide regulatory input for product recalls and recall communications. Job specific responsibilities may include (choose applicable areas and expand as appropriate). Manage and oversee the preparation of high-quality global filings for sustaining changes and new product registration. Manage rest of world (all geographies outside the US and EU) submissions. Serve as a regulatory team member on product development and sustaining teams, providing clear, concise regulatory strategy to ensure applicable global requirements are met for product development and quality system products. Assist company SME’s to interpret existing or new regulatory requirements for company products and procedures, labeling, marketing projects, testing and record keeping. May anticipate and advise on future regulatory trends and direction and recommend preemptive approaches for company regulatory. Proactively track global regulatory requirement changes and work with Global Strategic Intelligence (GSI) team to disseminate the information to all team members. REQUIRED QUALIFICATIONS Bachelors Degree (± 16 years) Related field OR an equivalent combination of education and work experience Masters Degree (± 18 years) In Regulatory Affairs preferred and may be used in lieu of direct regulatory experience. Minimum 3 years 3-4 years experience in a regulated industry (e.g., medical products, nutritionals). 2-3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.). Knowledge of: Regulatory history, guidelines, policies, standards, practices, requirements and precedents. Regulatory agency structure and processes. Principles and requirements of applicable regulations and agency guidance. Submission/registration types and requirements. GxPs (GCPs, GLPs, GMPs). Principles and requirements of promotion, advertising and labeling. Ethical guidelines of the regulatory profession. Communication Skills or Ability to: Communicate effectively verbally and in writing. Communicate with diverse audiences and personnel. Write and edit technical documents. Work with cross‑functional teams. Work with people from various disciplines and cultures. Negotiate internally and externally with regulatory agencies. Cognitive Skills or Ability to: Pay strong attention to detail. Manage projects. Create and maintain project plans and timelines. Think analytically. Organize and track complex information. Exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Has broad knowledge of various technical alternatives and their potential impact on the business. Exercise good and ethical judgment within policy and regulations. Use in-depth knowledge of business functions and cross‑group dependencies/ relationships. Define regulatory strategy with supervision. Follow scientific arguments, identify regulatory scientific data needs and with supervision solve regulatory issues. The base pay for this position is $90,000.00 – $180,000.00 In specific locations, the pay range may vary from the range posted. JOB FAMILY: Regulatory Operations DIVISION: SH Structural Heart LOCATION: United States > Santa Clara : Building A - SC ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: No MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday) Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: is the Law link - Espanol: #J-18808-Ljbffr