Senior Regulatory Affairs Specialist

Assess regulatory intelligence to assist in the development of local, regional, and global regulatory strategies. Participate in advocacy activities of a technical, tactical, or strategic nature. Evaluate the regulatory environment and provide internal guidance throughout the product lifecycle, including concept, development, manufacturing, and marketing, to ensure product compliance. Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions. Identify requirements and potential obstacles for market access distribution, including federal, provincial/territorial, state, reimbursement, and purchasing groups. Assist in the development of regulatory strategy and update strategies based on regulatory changes. Evaluate proposed products for regulatory classification and jurisdiction. Determine local, national, and international requirements and options for regulatory submissions, approval pathways, and compliance activities. Provide regulatory information and guidance for product development and planning throughout the product lifecycle to regulatory groups and cross‑functional stakeholders. Compare regulatory outcomes with initial product concepts and recommend changes or refinements based on regulatory outcomes. Negotiate with regulatory authorities throughout the product lifecycle. Identify the need for new regulatory procedures and SOPs and participate in their development and implementation. 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 and sustaining teams. Advise stakeholders on regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations. Assess the acceptability of quality, preclinical, and clinical documents for submission filing to comply with applicable regulations. Evaluate proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and develop strategies for changes that do not require submissions. Provide guidance on preapproval inspections, GCP inspections, and clinical investigator relationships. Identify, monitor, and submit applicable reports or notifications to regulatory authorities. Provide regulatory information and guidance for proposed product claims and labeling. Ensure clinical and nonclinical data, in conjunction with regulatory strategy, align with regulatory requirements and support proposed product claims. Prepare and submit electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines. Monitor the progress of regulatory authority review processes through appropriate communication channels. Communicate and interact with regulatory authorities before and during the development and review of regulatory submissions. Collaborate with cross‑functional teams during interactions with regulatory authorities, including panel meetings and advisory committees. Perform remediation of regulatory documentation in accordance with relevant regulatory requirements for US 510(k). Perform remediation of EU MDR Technical Documentation Files in accordance with relevant regulatory requirements for Class IIa medical devices. Qualifications Bachelor's degree in Engineering, Science, or a related field; or Master's degree in Regulatory Science. Minimum of 6 years of relevant experience. Master's degree or RAC certification preferred. Thorough knowledge and understanding of US and international medical device regulations, including direct experience with US 510(k) submissions and EU Class IIa devices. Working knowledge of EU MDR Class IIa requirements with expertise in maintaining Technical Documentation Files. Experience with regulatory strategy and operations. Demonstrated knowledge of regulatory pathways, risk‑benefit analysis, submission and registration processes, documentation, compliance, postmarketing surveillance/vigilance, distribution, and obtaining regulatory approvals. Strong communication and collaboration skills with internal and external stakeholders. Ability to plan, conduct, and supervise assignments under general supervision. Ability to proactively review progress, evaluate results, and recommend procedural changes. Capable of operating with appreciable latitude for independent action and decision‑making. Ability to review progress with management and communicate effectively. Demonstrated ability to seek out and apply diverse ideas, opinions, and insights. Strong interpersonal skills with the ability to work effectively with individuals who think and act differently. Receptive to feedback and committed to continuous improvement. Ability to evaluate risks, tradeoffs, timing, and available resources to determine the best course of action. Ability to navigate organizational dynamics, alliances, and competing priorities. Willingness to accept challenging assignments and new opportunities that build capabilities. #J-18808-Ljbffr