Staff Regulatory Affairs Specialist (Hybrid)

Job Description Summary

The Staff Regulatory Affairs Specialist is responsible for regulatory review and strategies for routine, moderate and highly complex post-market changes and accountable for developing and executing sound strategies for regulatory submissions and registrations for complex new product development projects. This associate will provide regulatory guidance to cross-functional business teams, change control review boards and coordinate support for sustaining engineering teams concerning regulatory requirements for notification, submission and compliant implementation of proposed changes to products and processes.
Provides instruction, guidance, and regulatory interpretations to functional staff and Core Teams to achieve rapid worldwide clearance/approval/registrations of BDDS Molecular Diagnostics products with desired claims

• Develops regulatory strategies for compliant implementation of proposed routine, moderately and highly complex changes to on-market products and processes. These strategies include seeking regulatory input from regional associates and formal communication of the proposed changes through the Notice of Change or Product Development Notification Process.
• Develops regulatory strategies for moderately to highly complex submissions to FDA and other regulatory agencies. Will prepare or coordinate the preparation of Pre-IDE, PMA, De Novo Petition, and 510(k) submissions. Provides risk assessments of strategies and regulatory options to business teams and to product development/support teams. Exercises considerable latitude in determining how to most efficiently organize activities to complete these submissions.
• Provides risk-based regulatory assessments of strategies, guidances and regulatory compliance options to cross-functional business teams, Sustaining Engineering Teams and Change Control Review Boards.
• Responsible for preparing and submitting PMA Supplements for on-market US Class Ill Devices to include Manufacturing Site Changes, Special PMA Supplements for Changes Being Affected, 30-day Notices and Annual Reports for on-market US Class Ill devices. Coordinates with Regulatory Affairs Specialists pre-market to ensure post-market supplements minimize complexity to potential premarket submissions. Exercises considerable latitude in determining how to most efficiently organize activities to complete these submissions.
• Provide support in interactions with regulatory authorities concerning post-market compliance activities. Plays a prominent role in negotiations with Notified Bodies regarding (1) Technical File Audits and recertification processes and (2) notifiable changes made to CE marked products.
• Prepares or provides input into Technical Documentation Package for CE marking, and interfaces as needed with Notified Bodies regarding significant changes to products.
• Provides regulatory affairs review, assessment, and guidance for convened routine and complex Situation Analyses Assessments as needed.
• Communicates (oral/written) with senior BD leadership as well as functional teams. Assesses and independently responds to feedback. Prepares formal written reports/documents for distribution within work unit and regions.
• Interprets statutes, regulations, policies and guidances for business teams and product development/support teams, communicating what the potential impacts are on product development, manufacturing, and/or marketing.
• Remains current on regulatory issues/trends affecting business unit products, assessing and communicating their impact to RA colleagues, product development/support teams, and to others in the business. Provides training or presentations in multiple subject areas to cross-functional groups across BD on a variety of regulatory topics.
• Recognizes potential problems, including situations that include ambiguity, by actively reviewing and analyzing internal and external factors. Assesses potential impact and/or applicability to other related areas. Assesses corrective action to assure it prevents recurrence. Able to confidently deal with ambiguous issues and provide input towards suitable actions.
• Suggests significant opportunities for improvement (cost, cycle time, quality, etc.) that are complex or involve multiple organizational areas. Analyzes feasibility and participates in developing, executing, or monitoring implementation plan.
• Independently manages and supervises multiple sophisticated, novel, and/or diverse projects simultaneously, including projects that involve several functional areas without direct supervision. Maintains a "focused urgency" as required by specific events.
• Formulates short term planning for individual deliverables and participates in long term planning within the unit. Includes signature authority for associated documents.
• Acts as a mentor to others within the department. Is aware of colleague's career goals, suggests development plans and allows others to accept developmental tasks. Participates in frequent development discussions, helping and encouraging them to accept developmental tasks or projects.

• Bachelor's degree in science, engineering, or related field. Masters or higher preferred
• RAPS Certification preferred
• Minimum 5 years of directly related regulatory experience in the medical device and/or in vitro diagnostic device area(s) preferred.
• Demonstrated experience in interpreting subjective and complex aspects of specific regulations and has thorough understanding of multiple sets of associated regulations.
• Demonstrates in-depth understanding of advanced technical/scientific principles that relate to multiple, diverse, and or complex product lines or manufacturing processes. May be recognized internally as technical or subject matter expert in multiple areas.
• Demonstrated success in supporting product development and product support projects, including complex projects involving ambiguity and rapid change.
• Demonstrated success in preparing, filing and completing (including negotiations) regulatory new product and post market submissions/dossiers (e.g., PMA supplements, Annual Reports, Technical Files).

• Knowledge of US FDA regulations and policies applying to medical devices and in vitro diagnostic devices including, but not limited to, requirements for 510(k)s, IDEs, PMAs, labeling and promotional materials, and Research Use Only devices. Must be able to interpret regulatory requirements, determine what is necessary for compliance, and effectively communicate this information to stake holders.
• Knowledge of EU regulations including, but not limited to, MOD 93/42/EEC and IVDMDD 98/79/EC. Must be able to interpret regulatory requirements, determine what is necessary for compliance, and effectively communicate this information to stake holders.
• Working knowledge of 21 CFR 820 - Quality System Regulation, ISO: 13485, ISO: 9001, Good Clinical Practice, and Good Laboratory Practice.
• Working knowledge of regulatory and quality standards applicable to business unit products.
• Ability to analyze complex issues and to formulate cogent approaches to resolving/addressing issues.
• Ability to exercise independent judgment and discretion within a broadly defined range of policies and practices.
• Ability to handle multiple tasks and to prioritize and schedule work to meet business needs. Minimal supervision required.
• Ability to think strategically, to detect the essence of complex or ambiguous issues, and to put these in the context of larger, systemic issues.