Staff Regulatory Affairs Specialist
Sparks, NV 89436
Location: Sparks, NV
Company: Top Medical Device Company
Compensation: $100K-$125K Base + Bonus + Amazing Benefits
Contact: Ken Kupersmith- [email protected]
The Staff Regulatory Affairs Specialist is responsible for executing 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. Proficient project/people management skills. Represents Molecular Diagnostics in pivotal interactions/negotiations with regulatory agencies and participates in external efforts to influence policymaking bodies.
1.Develops regulatory strategies for moderately to highly complex submissions to FDA and other regulatory agencies.
2.Will prepare or coordinate of Pre-IDE, PMA, De Novo Petition, and 510(k) submissions.
3.Prepares or provides input into Technical Files for CE marking, and interfaces as needed with Notified Bodies regarding significant changes to products.
4.Represents the business in interactions with regulatory authorities
5.Provides training or presentations in multiple disciplines to cross-functional groups across firm on a variety of regulatory topics.
6.Recognizes potential problems, including situations that include ambiguity, by actively reviewing and analyzing internal and external factors.
7.Suggests significant opportunities for improvement (cost, cycle time, quality, etc.) that are complex.
8.Inspires effective unit dynamics and imparts a sense of commitment to unit goals.
9.Includes signature authority for associated documents.
10.Carries out and adjusts task and activities based on financial and budgetary considerations.
1.B.S. degree or higher in a technical discipline preferred,
2.RAPS Certification preferred
3.Minimum 5 years of directly related regulatory experience in the medical device and/or in vitro diagnostic device area(s).
4.Demonstrated success in preparing, filing and completing (including negotiations) regulatory submissions/dossiers (e.g., 510(k), IDE, PMA, Technical Files).
5.Ability to handle multiple tasks and to prioritize and schedule work to meet business needs. Minimal supervision required.
Knowledge of Specific Procedures/Practices:
1.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 stakeholders.
2.EU regulations including, but not limited to, MDD 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 stakeholders.
3.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.
Looking for candidates with regulatory affairs experience supporting R&D IVD, leading RA projects for new product developments. Need to have worked with large matrix teams.