Contract: Senior Regulatory Affairs Specialist IV / US

Senior Regulatory Affairs Specialist IV - 934419

Job Description:

• Must be a collaborative facilitator, building consensus while championing global regulatory initiatives for projects.
• Providing pre- and postmarket regulatory initiatives for immunoassay devices, ensuring the development and implementation of these advanced and aggressive regulatory strategies provide a competitive edge to the client.
• Author premarket submissions, including 510(k)s and PMA supplements to the U.S.
• FDA in alignment with pre-market strategies.
• Working through the client'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.
• Using knowledge of global regulatory requirements achieve strategies that focus on speed to market and successful submissions to obtain approval in an efficient timely manner.
• Ensure business teams consider the impact of current or emerging regulatory issues, works with Global Regulatory Affairs and other regulatory colleagues to facilitate and ensure company practices are consistent with the corporate regulatory risk posture.
• 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 Danaher Business System (DBS) 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.

Skills/Qualifications:

• A 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.

EXPERIENCE PREFERRED:

• Fifteen years of relevant experience in a regulated medical device/diagnostic industry.
• 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.
• Experience in registration and commercialization of medical device and diagnostic products.
• Ability to develop effective regulatory strategies and apply regulations to premarket strategies.
• 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 are not required but training and certificates in quality or regulatory affairs would be a plus (e.g. CQM, CQE, CQA, RAC, CLIA, Six Sigma, Lean