iMPact Business Group
Regulatory Affairs Specialist-Medical Device (Cary)
iMPact Business Group, Cary, Illinois, United States, 60013
Position Description (Principle Duties and Responsibilities)
Analyzing links between global, societal, and economic trends; stakeholder concerns and regulatory issues; and the implications for regulatory strategy. Remediating regulatory documentation in accordance with relevant regulatory requirements for US 510(k) submissions. Remediating EU MDR Technical Documentation Files in accordance with regulatory standards for Class IIa medical devices. Developing and updating global, regional, and multi-country regulatory strategies, and aligning them with organizational goals. Providing guidance to integrate regulatory considerations into global product entry and exit strategies. Assessing all requirements and potential obstacles for market access and distribution (federal, provincial/territorial/state, reimbursement, purchasing groups) and developing solutions to address anticipated barriers. Critically evaluating the impact of changing regulations on preapproval and post-approval strategies and approaches. Negotiating with regulatory authorities on complex issues throughout the product lifecycle. Establishing working relationships and interfaces with multiple government and non-government organizations affecting market access and distribution. Identifying the need for and managing the development and execution of new regulatory procedures and standard operating procedures. Developing and managing programs that train stakeholders on current and new regulatory requirements to ensure organization-wide compliance. Evaluating risks related to product and clinical safety issues during clinical phases and recommending appropriate regulatory solutions. Evaluating proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposing plans for modifications that do not require submissions. Reviewing and assessing proposals submitted to regulatory authorities regarding regulatory paths and clinical plans. Providing regulatory guidance on strategies for proposed product claims and labeling. Ensuring clinical and nonclinical data align with regulatory requirements and support the proposed product claims. Preparing cross-functional teams for interactions with regulatory authorities, including panels and advisory committees.
What you need
Bachelor's degree in Life Sciences, Healthcare, or a related field. Several years of experience in regulatory affairs within the medical device or healthcare industry, ideally in a global or multi-regional capacity. Deep understanding of US FDA 510(k) processes and EU MDR technical documentation requirements. Experience in developing and updating regulatory strategies for global, regional, and multi-country markets. Strong analytical skills to assess regulatory requirements, obstacles to market access, and potential compliance risks. Ability to interpret and apply evolving regulatory standards and guidelines. Excellent communication skills for negotiating with regulatory authorities and guiding cross-functional teams. Proven ability to develop and manage regulatory procedures and training programs. Experience working with Class IIa medical devices. Familiarity with clinical and preclinical data evaluation and regulatory submissions. Knowledge of reimbursement, procurement, and market access considerations.
Analyzing links between global, societal, and economic trends; stakeholder concerns and regulatory issues; and the implications for regulatory strategy. Remediating regulatory documentation in accordance with relevant regulatory requirements for US 510(k) submissions. Remediating EU MDR Technical Documentation Files in accordance with regulatory standards for Class IIa medical devices. Developing and updating global, regional, and multi-country regulatory strategies, and aligning them with organizational goals. Providing guidance to integrate regulatory considerations into global product entry and exit strategies. Assessing all requirements and potential obstacles for market access and distribution (federal, provincial/territorial/state, reimbursement, purchasing groups) and developing solutions to address anticipated barriers. Critically evaluating the impact of changing regulations on preapproval and post-approval strategies and approaches. Negotiating with regulatory authorities on complex issues throughout the product lifecycle. Establishing working relationships and interfaces with multiple government and non-government organizations affecting market access and distribution. Identifying the need for and managing the development and execution of new regulatory procedures and standard operating procedures. Developing and managing programs that train stakeholders on current and new regulatory requirements to ensure organization-wide compliance. Evaluating risks related to product and clinical safety issues during clinical phases and recommending appropriate regulatory solutions. Evaluating proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposing plans for modifications that do not require submissions. Reviewing and assessing proposals submitted to regulatory authorities regarding regulatory paths and clinical plans. Providing regulatory guidance on strategies for proposed product claims and labeling. Ensuring clinical and nonclinical data align with regulatory requirements and support the proposed product claims. Preparing cross-functional teams for interactions with regulatory authorities, including panels and advisory committees.
What you need
Bachelor's degree in Life Sciences, Healthcare, or a related field. Several years of experience in regulatory affairs within the medical device or healthcare industry, ideally in a global or multi-regional capacity. Deep understanding of US FDA 510(k) processes and EU MDR technical documentation requirements. Experience in developing and updating regulatory strategies for global, regional, and multi-country markets. Strong analytical skills to assess regulatory requirements, obstacles to market access, and potential compliance risks. Ability to interpret and apply evolving regulatory standards and guidelines. Excellent communication skills for negotiating with regulatory authorities and guiding cross-functional teams. Proven ability to develop and manage regulatory procedures and training programs. Experience working with Class IIa medical devices. Familiarity with clinical and preclinical data evaluation and regulatory submissions. Knowledge of reimbursement, procurement, and market access considerations.