Req: Staff Regulatory Affairs Specialist (remote)
Duration: Direct Hire (Fulltime)
The Staff Regulatory Affairs Specialist is responsible and accountable for developing and executing sound strategies for regulatory submissions and registrations for complex new product development projects. This position interfaces with multiple projects and functional teams with limited oversight, provides instruction, guidance, and regulatory interpretations to functional staff and Core Teams to achieve rapid worldwide clearance/approval/registrations of BDDS Molecular Diagnostics / Women’s Health and Cancer products with desired claims. Proficient project/people management skills, establishes/achieves schedules and milestones for functional projects, provides performance feedback. Represents BDDS Molecular Diagnostics and Women’s Health and Cancer in pivotal interactions/negotiations with regulatory agencies, and participates in external efforts to influence policy making bodies and standards development organizations.
- 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.
- Prepares or provides input into Technical Files for CE marking, and interfaces as needed with Notified Bodies regarding significant changes to products.
- 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.
- 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 guidance documents for business teams and product development/support teams, communicating how these impact 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 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 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 frequent development discussions, helping and encouraging them to accept developmental tasks or projects.
- Makes recommendations for components of the local budget. Carries out and adjusts task and activities based on financial and budgetary considerations.
Education and Experience:
- S. Degree or higher in a technical discipline preferred, to include engineering, bioengineering, microbiology, molecular biology, cell biology, or chemistry.
- RAPS Certification preferred
- Minimum 5 years of directly related regulatory experience in the medical device and/or in vitrodiagnostic 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/or product support projects, including complex projects involving ambiguity and rapid change.
- Demonstrated success in preparing, filing and/or 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.
Knowledge of Specific Procedures/Practices:
- FDA regulations and policies applying to medical devices and in vitrodiagnostic 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 stakeholders.
- EU regulations including, but not limited to, MDD 93/42/EEC, IVDD 98/79/EC, MDR 2017/745, and IVDR 2017/746. Must be 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 9001:2000, EN ISO 13485, EN ISO 14971, Good Clinical Practice, and Good Laboratory Practice.
- Working knowledge of standards applicable to business unit products.
ISO 9001:2015; ISO/IEC 27001:2013; ISO/IEC 20000-1:2011; CMMI DEV/3; and CMMI SVC/3
Certified by USPAACC, NMSDC, WBENC
Affirmative Action/Equal Opportunity Employer