Senior Regulatory Affairs Specialist IV
Our client’s contribution to healthcare is offering a range of diagnostic solutions, clinical data management tools and process management expertise. Their goal is to provide solutions improving healthcare around the globe.
Our client has an opportunity for a Senior Regulatory Affairs Specialist IV. In this role they are looking for a high-level strategist, individual contributor and subject-matter-expert responsible for creating and executing regulatory strategies for pre- and post-market activities as well as the ability to manage complex issues that may have significant impact on the business.
- Collaborative facilitator, building consensus while championing global regulatory initiatives for projects.
- Provide pre- and post-market regulatory initiatives for immunoassay devices, ensuring the development and implementation of these advanced and aggressive regulatory strategies provide a competitive edge
- Author premarket submissions, including 510(k)s and PMA supplements to the U.S. FDA in alignment with pre-market strategies
- Work through the company’s design controls for product changes to determine when new registrations may be required due to design change
- Create / Manage Technical Files in compliance with IVDD and IVDR
- Work with international colleagues on establishing design dossiers for their intended market
- Collaborate with international Regulatory Affairs professionals to support global product registrations
- Ensure sound premarket product regulatory strategies include the timely and consistent review of post-market activities, such as adverse events and recall notification, minimizing the risk of negative premarket submission actions, including agency review delays
- Communicate with regulatory agencies in the US, Canada, the EU and other geographic areas, as required
- Collaborates across the organization at all levels, across functional groups and geographic locations, including executive management; manage matrices effectively.
- Utilize Business System tools to drive compliance and effective processes; developing regulatory metrics and scorecards and institute data-based process improvements which will align with corporate and business unit goals.
Salary: $50-53/hr DOE (contract)
Schedule: M-F 8am – 5pm
Benefits: Medical and Dental available
- Bachelor’s degree with 9+ years of experience
- or Master’s degree with 7+ years of regulatory experience, preferably in areas of life sciences, engineering, or quality assurance
- An advanced scientific degree is strongly preferred
Preferred experience to be successful in this role
- 15 years of relevant experience in a regulated medical device/diagnostic industry
- A subject matter expertise in regulatory affairs for medical devices and in vitro diagnostics
- Demonstrated knowledge and understanding of regulations and guidelines governing the areas of medical devices and IVD (in vitro diagnostics)
- Previous experience in registration and commercialization of medical device and diagnostic products
- Ability to develop effective regulatory strategies and apply regulations to premarket strategies
- Ability to possess a broad knowledge of surrounding areas including Quality Assurance, Manufacturing and Development
- Proven leadership and managerial skills in order to build and sustain a vision for the work group
- Demonstrated track record of developing organizational capability
- Global experience leading and/or participating on cross functional teams
- Professional designations (e.g. CQM, CQE, CQA, RAC, CLIA, Six Sigma, Lean) – A Plus!
- Training and certificates in quality or regulatory affairs - A Plus!