Staff Regulatory Affairs Specialist
Baltimore, MD 21210
Location: Baltimore, Maryland
Industry: Medical Devices
Job Category: Regulatory Affairs & Compliance Law
Contact: Ken Kupersmith
The Staff Regulatory Affairs Specialist is responsible for developing and executing strategies for regulatory submissions for complex new medical devices. This position interfaces with multiple functional teams with limited oversight, provides instruction, guidance, and regulatory interpretations to functional staff to achieve worldwide approvals of Molecular Diagnostics products with desired claims. Proficient project and people management skills, establishes and achieves schedules and milestones for functional projects. Represents Molecular Diagnostics in pivotal interactions and negotiations with regulatory agencies, and participates in external efforts to influence policymaking bodies and standards development organizations.
1.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.
2.Represents the business in interactions with regulatory authorities.
3.Interprets statutes, regulations, policies and guidances for business teams and product development/support teams, communicating how these impact product development, manufacturing, and/or marketing.
4.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.
5.Formulates short term planning for individual deliverables and participates in long term planning within the unit. Includes signature authority for associated documents.
1.B.S. degree or higher in a technical discipline preferred, to include engineering, bioengineering, microbiology, molecular biology, cell biology, or chemistry. RAPS Certification preferred
2.Minimum 5 years of directly related regulatory experience in the medical device and/or in vitro diagnostic device area(s).
3.Demonstrated experience in interpreting subjective and complex aspects of specific regulations and has thorough understanding of multiple sets of associated regulations.
4.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.
5.Demonstrated success in supporting product development and product support projects, including complex projects involving ambiguity and rapid change.
6.Demonstrated success in preparing, filing and completing (including negotiations) regulatory submissions/dossiers (e.g., 510(k), IDE, PMA, Technical Files).
7.Ability to analyze complex issues and to formulate cogent approaches to resolving/addressing issues.
8.Ability to exercise independent judgment and discretion within a broadly defined range of policies and practices.
9.Ability to handle multiple tasks and to prioritize and schedule work to meet business needs.
Knowledge of Specific Procedures/Practices:
1.FDA & EU 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.