Regulatory Affairs Specialist III

Werfen•Bedford, MA

About The Position

This position is responsible for ensuring that pre‑market and/or post‑market regulatory activities for digital health products follow applicable domestic and international regulations and guidance. Working independently, with guidance from management or senior regulatory staff, the position will participate in cross‑functional software development meetings; prepare software‑specific submission and registration documentation; assess and document software changes, cybersecurity impacts, and algorithm updates. This role is technically focused and requires advanced skills in analyzing software medical device products and regulations, reviewing verification/validation protocols and reports, evaluating risk management documentation, authoring regulatory documents for agile/iterative development environments, and promoting compliance with global digital health requirements.

Requirements

Ability to read and interpret domestic and international regulatory/quality standards related to our products
Working knowledge of IL products, technology, and regulatory requirements, including impact on customers and patient requirements
Demonstrates judgment commensurate with experience regarding application of regulatory requirements to data review, protocols, reports, design changes, etc. to ensure compliance and achieve business objectives
Recognition of when to escalate issues to management or consult with more senior staff members.
Attention to Detail: Ability to pay close attention to detail is required
Accuracy: Work is accurate and complete
Performance Standards: Demonstrated ability to meet department goals
Communication: Excellent written, verbal and presentation skills
Discretion: Acts with integrity in all situations and can maintain appropriate confidentiality
Multi-Tasking: Ability to manage multiple priorities, and support changing business needs
Collaboration: Ability to work within a team to bring best solutions to the team or customer
Independence: self-motivated-works under minimal supervision
Professionalism: Must demonstrate professionalism during all interactions within company, customer and third parties
Takes Initiative: Serves as a role model for "Quality First" by continuously improving on what matters most to customers
Problem Solving: Promptly and effectively handles issues and problems
Decision Making: Makes decisions based on data and risk determination
Bachelor's degree or higher, preferably in science and/or regulatory
Minimum of 5-years' experience in medical devices, in vitro diagnostics, pharmaceuticals or clinical laboratory or 2 years' experience with an advanced degree
Duties necessitate broad and thorough knowledge of regulatory and compliance requirements, including domestic and international regulations
Understanding of the application of regulatory principles in the areas of pre-market or post-market compliance
Knowledge of FDA, ISO, MDSAP and international country regulations
Knowledge of design control requirements and understanding of GMP
Language: English

Responsibilities

Advise and direct teams on regulatory requirements related to new product development or significant changes
Ensure test protocols and reports for new products or significant product changes meet regulatory requirements for intended market(s)
Author regulatory plans as regulatory lead for new products or significant product changes, including interfacing with country market approval holders to confirm local regulatory requirements
Act as lead on regulatory filings for market clearance, licensing, registration, and legalization, both domestic and international
Review and approve labeling and marketing materials associated to regulatory filings
Advise and direct teams on regulatory requirements for on-market product changes
Author regulatory determinations as regulatory lead for on-market product changes, including interfacing with country market approval holders to confirm local regulatory requirements
Ensure company site and device registrations are compliant with applicable domestic and international regulations
Review and approve changes orders for product labeling changes, regulatory procedure changes and marketing communications as required
Increase working knowledge of regulations, standards, company SOPs and tools
Assist in interactions regarding regulatory affairs with all functional areas of the company as required including senior management
Assist in tracking standards, regulations and all applicable requirements
Assess regulatory gaps and take the appropriate corrective actions, as needed
Supports internal and external audit as required
Participates in regulatory improvement projects as required