Sr. Regulatory Affairs Specialist - Medical Device
Employment Type: Full-Time
Industry: Healthcare - Allied Health
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Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.
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: Leverage MS Excel and project management tools to track and provide team updates on progress against project deliverables. Facilitate negotiations to what is aggressively achievable to exceed Division timeline expectations. Update Regulatory Information System as information is acquired to support future submissions. Work with project team to develop key deliverables that need to be tracked and managed. Manage detailed plans and anticipate possible road blocks to meeting plan. Regulatory Assess hardware and software changes to determine impact on on-market products. Approve Global Service and Support Technical Service Bulletins Participate on cross-functional teams as the Subject Matter Expert Assess emerging Regulations against Quality System. Perform a Regulatory Assessment and recommendation.
Premarket: Work with project team to develop key deliverables that need to be tracked and managed. Manage detailed plans and anticipate possible road blocks to meeting plan. Take ownership of the project and develop effective working relationships and communication with team members and business partners to develop plans to meet the timelines, then follow up on those deliverables to hold self and others accountable for commitments. Work independently and with team members to identify and then mitigate risks/issues. Assess the acceptability of quality, technical documentation for 510(k) submissions and PMA 180-day Supplements 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 Engineering manufacturing changes for regulatory filing strategies Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval
Postmarket: Maintain annual licenses, registrations, and listings Assist compliance with product post-marketing approval requirements; Experience in CAPA Review and approve advertising and promotional items to ensure regulatory compliance Assess external communications relative to regulations Review 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 Ensure product safety issues and product-associated events are reported to regulatory agencies Provide regulatory input for product recalls and recall communications
Qualifications: Bachelor's Degree (or equivalent); Bachelors Degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.) 2-3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. 3-4 years experience in a regulated industry (e.g., medical products, nutritionals). MDSAP knowledge a plus. ISO13485, IEC61010, ISO 9001 knowledge. Change control, Engineering Controls, Risk Management
Preferred Experience, Education, etc.: Bachelor's Degree in Engineering (e.g. Mechanical, Electrical, or similar), highly preferred. 3 (+) years' Regulatory work experience from medical device industry or similar industry.
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