Job Description Summary

Reporting to the Senior Manager, Regulatory Affairs, Microbiology, the Staff Regulatory Affairs Specialist is responsible for the preparation of strategies for moderately to highly complex regulatory submissions required to market new or modified medical devices and in vitro diagnostic devices in both domestic and international clinical markets. This position interfaces with multiple projects and functional teams with limited oversight, provides instruction, guidance, and regulatory interpretations to Core Teams and to functional staff to achieve rapid worldwide clearance/approval/registrations of products with desired claims and maintain compliant post-market change management. Represents BD in pivotal interactions/negotiations with regulatory agencies and participates in external efforts to influence policy making bodies and standards development organizations. Able to use project management tools to facilitate development and communication of predictable regulatory deliverables that maximizes opportunity for regulatory success.

• Develops regulatory strategies for moderately to highly complex submissions to FDA and other regulatory agencies. Prepares or coordinates the preparation of Pre-IDEs, PMA, PMA Supplements, 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.
• Represents the business in interactions with regulatory authorities. Plays a prominent role in complex negotiations regarding (1) clinical and analytical study designs during the pre-submission phase and (2) acceptable claims, wording, performance data and other information at the pre-clearance/approval phase.
• Prepares Technical Files for CE marking, to include obtaining documentation and support from Quality to maintain compliance, and interfaces as needed with Notified Bodies regarding significant changes to products. Provides subject matter expertise during Technical Audits by Notified Bodies to maintain design certificates.
• Organizes and manages meetings with regulators, including development of agendas and training/preparation of company personnel attending these meetings.
• 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 the impact 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 disciplines to cross-functional groups across BD on salient 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 monitors multiple complex, 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.
• Inspires effective unit dynamics and imparts a sense of commitment to unit goals. Encourages and empowers others to achieve. Recognized as a leader within division (for example PDT, business or unit LT, RLT, RSC).
• 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 development discussions, helping and encouraging colleagues as they accept developmental tasks or projects.
• Makes recommendations for components of the local budget. Carries out and adjusts tasks and activities based on financial and budgetary considerations.

• B.S. degree or higher in a technical discipline preferred, to include engineering, bioengineering, microbiology, molecular biology, cell biology, or chemistry. RAPS RAC (Medical Devices, or U.S. under legacy certificate system) preferred.

• Minimum 5 years of directly related regulatory experience in the medical device and/or in vitro diagnostic device area(s).

• 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 submissions/dossiers (e.g., 510(k), IDE, PMA, Technical Files).
• 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.

• 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. Able to interpret regulatory requirements, determine what is necessary for compliance, and effectively communicate this information to stakeholders.
• EU regulations including, but not limited to, MDD 93/42/EEC, MDR 2017/745, IVDD 98/79/EC, and IVDR 2017/746. Able to interpret regulatory requirements, determine what is necessary for compliance, and effectively communicate this information to stakeholders.
• 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.