Key Responsibilities and Required Skills for Regulatory Specialist

🎯 Role Definition

The Regulatory Specialist is a critical member of our team, responsible for developing and executing regulatory strategies to support product development and sustain market approval for our products globally. You will act as a key liaison between the company and various regulatory bodies, ensuring all submissions, documentation, and processes adhere to the highest standards of compliance. Your expertise will be vital in mitigating regulatory risks and enabling the company's growth objectives by ensuring our life-changing products reach patients and providers safely and efficiently.

📈 Career Progression

Typical Career Path

Entry Point From:

Regulatory Affairs Associate
Quality Assurance Specialist
R&D Engineer or Scientist with an interest in regulatory pathways

Advancement To:

Senior Regulatory Specialist
Regulatory Affairs Manager
Director of Regulatory Affairs

Lateral Moves:

Quality Systems Manager
Clinical Affairs Specialist
Product Compliance Engineer

Core Responsibilities

Primary Functions

Independently prepare, compile, and submit complex regulatory applications and submissions to global health authorities, including but not limited to FDA (510(k)s, PMAs, IDEs), Health Canada, and Notified Bodies for CE marking under MDR/IVDR.
Conduct thorough reviews of product labeling, instructions for use (IFU), advertising, and promotional materials to ensure strict compliance with applicable regulations, guidelines, and company policies.
Develop and execute global regulatory strategies for new product development and significant product modifications, assessing regulatory pathways and identifying potential risks and mitigation plans.
Act as a key regulatory representative during internal and external audits (e.g., FDA inspections, Notified Body audits), preparing documentation and responding to inquiries to demonstrate robust compliance.
Author, review, and maintain essential regulatory documentation, including Technical Files, Design Dossiers, and other submission-critical documents, ensuring they are consistently audit-ready.
Serve as a direct point of contact for regulatory agencies, effectively managing communications, responding to formal inquiries (e.g., Additional Information requests), and negotiating submission requirements to facilitate timely approvals.
Evaluate proposed product, process, and quality system changes for their impact on existing regulatory filings and approvals, determining the need for new submissions, letters to file, or notifications.
Proactively monitor, interpret, and analyze the impact of new or changing international and domestic regulations, standards, and guidance documents, communicating key insights and action plans to cross-functional stakeholders.
Provide robust regulatory support for clinical trials, including the preparation and submission of Clinical Trial Applications (CTAs/INDs) and subsequent amendments, and ensuring compliance with Good Clinical Practice (GCP).
Oversee the process for adverse event and medical device reporting (MDRs), ensuring timely and accurate assessments and submissions to the relevant competent authorities worldwide.
Collaborate closely with R&D, Quality Assurance, Manufacturing, and Marketing teams to provide regulatory guidance and input throughout the entire product lifecycle, from concept to commercialization and post-market.
Manage and maintain all necessary establishment registrations, device listings, and state/international licenses to ensure uninterrupted market access for all commercialized products.
Develop and execute post-market surveillance plans, including the analysis of vigilance data, complaint trends, and literature reviews, to support periodic safety update reports (PSURs) and other post-market requirements.
Perform comprehensive gap assessments of existing technical documentation and processes against new and evolving regulatory requirements (e.g., EU MDR/IVDR transition) and develop detailed remediation plans.
Maintain a comprehensive tracking system for all regulatory submissions, approvals, and agency correspondence, providing regular status updates to senior management and project teams.

Secondary Functions

Support business development activities by conducting regulatory due diligence on potential acquisitions, partnerships, or in-licensing opportunities.
Develop and deliver training programs to internal teams on relevant regulatory requirements, processes, and updates to foster a culture of compliance across the organization.
Coordinate with U.S. Agents and European Authorized Representatives to fulfill local regulatory obligations and facilitate communication with regional authorities.
Assist in the review and approval of marketing and sales materials to ensure claims are substantiated and compliant with regulatory standards.
Participate in industry trade associations and external forums to gather regulatory intelligence and contribute to shaping the regulatory environment.
Support ad-hoc data requests and exploratory data analysis related to compliance and post-market trends.
Contribute to the continuous improvement of regulatory affairs processes and procedures to enhance efficiency and effectiveness.
Participate in sprint planning and agile ceremonies within cross-functional product development teams, acting as the voice of regulatory compliance.

Required Skills & Competencies

Hard Skills (Technical)

Regulatory Submissions Expertise: Proven experience with preparing and managing regulatory submissions such as 510(k), De Novo, PMA, and CE Technical Files/Design Dossiers under MDR/IVDR.
Global Regulatory Knowledge: In-depth understanding of global medical device and/or pharmaceutical regulations, including FDA 21 CFR (e.g., 820, 803, 806), EU MDR 2017/745, and other international standards.
QMS Proficiency: Strong working knowledge of Quality Management Systems (QMS) and relevant standards, particularly ISO 13485:2016.
Technical Writing: Exceptional technical writing and documentation skills, with the ability to create clear, concise, and compliant regulatory documents for a scientific and regulatory audience.
Post-Market Activities: Familiarity with post-market surveillance, vigilance, complaint handling, and adverse event reporting requirements.
Regulatory Intelligence: Ability to research, interpret, and apply complex regulatory requirements and guidance documents to business and product development activities.

Soft Skills

Attention to Detail: Meticulous attention to detail and a high degree of accuracy, critical for error-free submissions and compliant documentation.
Communication & Interpersonal Skills: Excellent written and verbal communication skills, with the ability to articulate complex regulatory concepts to diverse technical and non-technical audiences.
Problem-Solving & Analytical Thinking: Strong analytical and problem-solving skills, capable of interpreting regulations, identifying risks, and developing strategic, compliant solutions.
Project Management & Organization: Effective project management and organizational skills, with a demonstrated ability to manage multiple priorities, projects, and tight deadlines simultaneously.
Cross-Functional Collaboration: A collaborative and team-oriented mindset with a proven ability to work effectively and build relationships with R&D, Quality, Marketing, and other internal partners.
Adaptability & Resilience: Ability to thrive in a fast-paced, dynamic environment and adapt to evolving regulatory landscapes and business priorities.

Education & Experience

Educational Background

Minimum Education:

Bachelor's Degree

Preferred Education:

Master's Degree or higher
Regulatory Affairs Certification (RAC)

Relevant Fields of Study:

Life Sciences (Biology, Chemistry, etc.)
Biomedical Engineering
Pharmaceutical Sciences
A related scientific or technical field

Experience Requirements

Typical Experience Range:

3-7 years of direct experience in a regulatory affairs role within the medical device, pharmaceutical, or biotechnology industry.

Preferred:

Direct experience interacting with regulatory agencies like the FDA, Health Canada, or EU Notified Bodies.
Experience with high-risk devices (Class IIb/III) or combination products is highly advantageous.