Associate Director Regulatory Affairs - Global Regulatory Services

The Opportunity The Associate Director Regulatory Affairs will work for our Global Regulatory Services division within Leveraged Services. As an Associate Director, the individual is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. This new team member will support key digital health technology activities (i.e., software, cybersecurity, telehealth, digital solutions, etc.) and be recognized as an expert and resource within the division. The individual should have a strong understanding of the software lifecycle management and software development, including design, validation, and maintenance in the device regulatory environment. Demonstrates ability to interpret and apply regulatory requirements to software systems, including documentation, risk management, and compliance strategies. Assists management and leadership on regulatory activities and works with the medical device business units that Leverage Services team supports, including the execution of strategic regulatory initiatives, regulatory submissions, agency relationship and evaluation of regulatory policies. The individual will apply strong communication skills, strategic thinking, and leadership experience to support the medical device business units with their regulatory submissions. Collaborates closely with internal regulatory colleagues to ensure project strategies and regulatory submissions meet global requirements, drawing on sound knowledge of medical device regulations and experience such as from the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH). This Associate Director Regulatory Affairs may analyze broad scope implications of changing regulations, guidance, or regulatory shifts. Additionally, may identify data needed, obtain this data, and ensure that the information is effectively shared across the medical device businesses. What You’ll Work On Review regulatory submissions involving software components (e.g., 510(k), PMAs, CE marking, technical files). Collaborate closely with internal regulatory colleagues to ensure project strategies and regulatory submissions meet global requirements Develops regulatory strategies with the medical device business units for new products or changing existing products especially with FDA Supports and provide critical review of key documents necessary for regulatory submissions for new products or changes to existing products. Ensure that regulatory submissions that contain digital health technologies (i.e., software, cybersecurity, telehealth, etc.) have targeted mitigations to align with FDA expectations, ensuring high-quality submissions and predictability for approval Assists BU RA at team meetings and applies influence and negotiation skills to resolve issues Works with BU RA to resolve deficiencies that may have received for submissions Maintains awareness of regulatory legislation, regulations, and guidances. Communicates with internal groups to share updates on regulatory changes as it pertains to the FDA Utilizes technical regulatory skills to proposed strategies on complex issues Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and update leadership Monitor impact of changing regulations on submission strategies and update internal stakeholders Provide strategic input and technical guidance on regulatory requirements to development teams as requested Identify and present option for risk mitigation to decision makers Support regulatory trackers for submissions to identify areas for new or continued training in order to implement appropriate regulatory strategies to mitigate risks Provide summary of key issues related to submissions at a high level to leadership Utilize technical regulatory skills to propose strategies on complex issues. Determine submission and approval requirements. Identify emerging issues. Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams. Evaluate risk of and regulatory solutions to product and clinical safety issues during clinical phases and recommend solutions. Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies. Required Qualifications Bachelor's degree Minimum 5 - 7 years’ experience in a regulated industry. Effectively communicate verbally and in writing, prepare, and negotiate both internally and externally with various regulatory agencies. Preferred Qualifications Bachelor's degree in science (biology; chemistry; microbiology; immunology; medical technology; pharmacy; pharmacology); math; engineering; or medical fields. M.S. in a technical area or MBA. A Ph.D. in a technical area or law is helpful. At least 5 years’ experience in regulatory affairs; highly preferred with medical devices. At least 5 years working directly with the FDA on medical devices Knowledge on PMAs, IDEs, 510(k)s : Past experience in strategic thinking, planning, preparing or reviewing and demonstrated experience with US submissions and a solid knowledge of FDA regulations Strong understanding of software lifecycle management, including design, validation, and maintenance in regulated environments. In-depth knowledge of regulatory frameworks (e.g., FDA, EMA, ISO 13485, GDPR) relevant to software products, especially in healthcare and medical devices. Ability to interpret and apply regulatory requirements to software systems, including documentation, risk management, and compliance strategies. Familiarity with cybersecurity and data privacy regulations as they pertain to software products Experience managing projects, planning and conducting meetings and leading teams to ensure completion of project tasks Previous experience with 510k / PMA / IDEs / Q-submissions. Must be able to juggle multiple and competing priorities. Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Ability to problem solve while being detailed oriented is critical Has a sound knowledge of a variety of alternatives and their impact on the business. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)

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