Senior Regulatory Affairs Specialist - IVD 510k submission to FDA

InnoTech Staffing•Salem, NH

7d•Hybrid

About The Position

InnoTECH Staffing is looking to hire a fulltime permanent Senior Regulatory Affairs Specialist who has experience with IVD 510k submission to the FDA. Preparing reports, working on Estar, handling on-market regulatory issues. This ideally would be 5 days onsite in Salem, NH but some remote work is ok. The Senior Regulatory Affairs Specialist is responsible in the development, implementation, and coordination of the company’s regulatory compliance programs. This role is responsible for filing all necessary regulatory applications, licenses, and industry related permits, and leading all government interactions pertaining to the regulatory filing process on all regulated products. The Senior Regulatory Affairs Specialist exercises independent regulatory judgment and serves as a key individual contributor supporting regulatory strategy and compliance across the product lifecycle. The company provides immunoassay-based products to the life science research and medical diagnostic industries. Customer segments include routine clinical labs, biotech/pharmaceutical R&D labs, CRO’s and academic research institutions. The company employs a hybrid distribution/manufacturing business model. The company's products are derived from organic R&D and cGMP production operations, as well as externally sourced products in the form of either OEM products, or products sold via pure distribution under the original manufacturer’s label.

Requirements

Working knowledge of FDA regulations associated with operating a high-quality manufacturing environment.
Bachelor’s Degree (Master’s preferred) and 8-12+ years in a GMP environment, In Vitro Diagnostic (IVD), Pharmaceutical, Life Science, Biotech or Medical Device experience preferred.

Responsibilities

Provide guidance on global regulatory strategy for product development programs and complex technical changes.
Lead and represent the Company in regulatory authority meetings, including FDA Q-Submissions (Pre-Subs), teleconferences, and written interactions, serving as the primary regulatory subject-matter expert for assigned programs.
Review and approval of field complaints to ensure ongoing regulatory compliance.
Monitor regulatory intelligence (e.g., FDA guidance, regulations, and policy updates) and assess potential impact to company products and regulatory strategy.
Accurately maintain the Company’s FDA device listing as well as Health Canada device licenses.
Develop and recommend successful regulatory strategies for new products/device submissions (i.e. both pre-submission and formal 510K Submissions).
Independently lead and coordinate cross functional input for the preparation and submission of quality applications in territories including marketing authorization applications, variations, renewals, and responses to questions.
Maintain up-to-date product labelling for all translation requirements.
Conduct internal audits, and actively participate and represent the Company in 3rd party quality audits, as well as regulatory audits and/or inspections, as assigned by VP of QARA.
Act as lead auditor in external vendor and/or supplier audits, as assigned by VP of QARA.
Provide regulatory analysis and recommendations to support product classification decision and submission pathways.
Play a supporting and/or backup role on broader Quality Assurance and QMS related responsibilities.