What are the responsibilities and job description for the Senior Regulatory Affairs Specialist position at TekOne IT Services Pvt. Ltd.?
Job Title: Senior Regulatory Affairs Specialist
Location: Princeton, NJ
Job Description
Location: Princeton, NJ
Job Description
- Regulatory Submissions: Compile, prepare, and review US 510k submissions and EU IVDR Technical Files to ensure compliance with applicable regulations.
- Regulatory Strategy: Anticipate and navigate regulatory obstacles throughout the product submission cycle, collaborating with regulatory and cross-functional teams to develop effective solutions.
- Lifecycle Planning: Provide regulatory input for product lifecycle planning, including assessing the impact of design changes on product registration in responsible regions.
- Regulatory Monitoring: Track the progress of regulatory applications, communicate updates to internal stakeholders, and ensure timely responses to regulatory authorities.
- Compliance Oversight: Ensure that all external communications for regulatory purposes are compliant with applicable regulations and that submissions meet the required standards for quality, preclinical, and clinical documentation.
- Strategic Guidance: Provide expert advice on regulatory requirements to development teams, helping to shape product development strategies and ensure successful submissions.
- Issue Identification: Identify emerging regulatory issues and assess their impact on product registrations in responsible regions.
- Lead projects and provide guidance to exempt and non-exempt personnel, offering direction and support without direct managerial authority.
- Influence and coordinate cross-functional teams to achieve regulatory objectives, ensuring deadlines are met with minimal oversight.
- Manage and execute technical and scientific regulatory activities independently, ensuring alignment with both short-term and long-term goals.
- Serve as a key negotiator and communicator with regulatory agencies, applying regulatory requirements effectively to ensure successful submissions.
- Exercise autonomy in determining the technical objectives of assignments, with work reviewed primarily from a long-term perspective.
- Education: Bachelor’s Degree in Science (Biology, Chemistry, Microbiology, Immunology, Medical Technology, Pharmacy, Pharmacology), Math, Engineering, or related fields. A Master’s Degree in a technical area is a plus.
- Experience: Minimum of 5 years of experience in a regulated industry, such as medical devices or pharmaceuticals.
- Certifications: RAC (Regulatory Affairs Certification) from the Regulatory Affairs Professionals Society is preferred but not required.
- Hands-on experience authoring US 510k submissions or EU IVDR Technical Files within the last 5 years.
- Practical experience working with in vitro diagnostic (IVD) medical devices.
- Proven ability to lead cross-functional teams on regulatory and compliance-related projects.
- Excellent technical writing skills with the ability to provide writing samples upon request.
- Strong communication skills, with the ability to effectively collaborate with internal teams and external regulatory bodies.
