Manager, Regulatory Affairs - Medical Device

Manager, Regulatory Affairs - Medical Device

PPD - Pharmaceutical Product Development

Multiple Locations

Job Description

The Manager Regulatory Affairs is responsible for regulatory leadership in project teams by providing regulatory guidance throughout the full product development cycle of medical devices, diagnostics, and combination products. Manages a team within the department or cross-functionally to provide innovative solutions and strategic regulatory support and guidance for product development from preclinical through registration and post-market. When serving as a Project Lead, the Manager Regulatory Affairs collaborates with other functions to assure the work of the entire team is delivered on time and that it meets client’s and CRG’s quality expectations. This includes creating and executing regulatory strategies, and preparation of regulatory submissions required to market new or modified medical devices, IVDs, combination products in the US and EU, along with supporting all other geographical regions registrations. Also includes support for related regulatory affairs activities, such as development and execution of procedures and systems designed to ensure that the regulatory and product development process, including clinical and performance evaluation studies, and non-clinical and analytical, addresses all regulatory requirements as well as the objectives of the business. May have direct supervisor responsibilities in addition to project team personnel; provides direction to assistant personnel.

We are currently looking for a candidate who will have the following responsibilities:

  • Assess regulatory pathways for new products and product modifications;
  • Understand and interpret EU and US medical device and in vitro diagnostic device (IVD) regulatory requirements;
  • Develop regulatory strategies and plans for submissions for international product registrations and investigational use;
  • Draft and prepare product technical documentation for CE marking activities and notified body interaction to accomplish EU MDR/IVDR product authorization and investigational use;
  • Draft and prepare 510(k), PMA, de novo and IDE submissions and lead process through clearance/approval;
  • Act as subject matter expert in providing regulatory strategy advice, technical expertise, and product development guidance to internal and external clients;
  • Support engagements with EU, US, and global regulatory agencies as required to confirm acceptability of regulatory strategy;
  • Review and/or develop analytical and clinical protocols, and device performance evaluation plans and reports to assure collection of appropriate data for regulatory submissions and regulatory compliance;
  • Finalize and review regulatory documents and submissions;
  • Review product labels, labeling, and promotional materials;
  • Identify and communicate potential risks and mitigations associated with regulatory strategies;
  • Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams;
  • Conduct impact assessment of changing regulations and guidance, and participate in advocacy;
  • Ensures compliance with relevant organizational and departmental SOPs and WPDs.

Job Qualification

Ideally you will have:

  • Bachelor's degree or equivalent and relevant formal academic/vocational qualification. Master's degree is a plus;
  • Minimum 5 years’ experience in regulatory affairs in the device/diagnostic industry;
  • 2+ year of leadership responsibility;
  • Solid understanding of global/regional/national country requirements and regulatory affairs procedures for clinical trial authorization, licensing and lifecycle management;
  • Working knowledge of EU and US IVD or Medical Device Regulatory requirements and quality system standards is required;
  • Working knowledge of investigational device requirements including 21 CFR Part 820, ISO 14155, ISO 20916, and ICH is required;
  • Experience in authoring technical files and working with notified bodies to obtain approval is required. Demonstrated experience in authoring FDA 510(k), PMA or de novo submissions, leading pre-submission meetings, is a plus;
  • Technical writing skills and be proficient at compiling successful submissions for the appropriate audience is required;
  • Demonstrated project management, negotiation, and communication (written and oral) skills to all levels within the organization and external to the organization;
  • Strong organizational, judgment, analytical, decision-making and interpersonal skills to manage complex projects in parallel and manage rapidly changing priorities;
  • Demonstrated ability to prioritize competing priorities and deadlines, and organize complex information;
  • Must be self-motivated by working independently and having the ability to take ownership of her/his responsibilities;
  • Capable of supervising, evaluating, and mentoring departmental personnel; Must be able to provide leadership and mentoring skills to less experienced regulatory personnel;
  • Capable of delegating tasks and facilitating the completion of assignments;
  • Demonstrated analytical thinking to comprehend and analyze an issue, and resolve problem;
  • Companion Diagnostic regulatory experience, understanding of CAP/CLIA and Laboratory Developed Tests (US) is a plus;
  • Demonstrated ability to interpret and implement new regulations and guidance.

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© EuroJobsites 2022

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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