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Senior Regulatory Affairs Project Manager
About PENTAX Medical
Our mission is to improve the standard of patient care and quality of healthcare delivery by providing the best endoscopic products and services with a focus on QUALITY, CLINICALLY RELEVANT INNOVATION, and SIMPLICITY. Through leading edge R&D and manufacturing, PENTAX Medical provides endoscopic imaging devices and solutions to the global medical community.
Position Opening : REGULATORY AFFAIRS – SENIOR PROJECT MANAGER
Why JOIN Us?
We are an established medical device leader that is preparing for high growth. This role will provide expertise in developing our essential engineering projects..
PENTAX Medical is proud of its comprehensive benefits program and generous Paid Time Off and Holiday policy.
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The Regulatory Affairs – Senior Project Manager supports the development of global regulatory strategies, including research device classification and evaluate predicate devices, create 510(k) submissions for a range of medical devices, and provide regulatory support for a broad range of international registration activities to ensure delivery of the safest and highest quality products while maintaining full regulatory compliance.
Responsibilities of the Regulatory Affairs – Senior Project Manager
Submission and Compliance Project Management – Develops, implements and manages systems to track required reports, supplemental submissions and postmarketing commitments.
Process Owner for Pentax Project Management Process, maintaining SOP/Work Instructions/Forms and providing training
Identifies regulatory pathways for initial product designs and provides input to internal stakeholders.
Assesses all requirements and potential obstacles for market access and distribution (federal, provincial/territorial/state, reimbursement, purchasing groups, IDN’s, etc.) and develops solutions to address anticipated obstacles.
Critically assesses the impact of changing regulations on preapproval and post approval strategies and approaches and advises internal stakeholders on a course of action to expedite development for products.
Negotiates with regulatory authorities on complex issues throughout the product lifecycle.
Establishes working relationships and interfaces with multiple government and non-government organizations having an impact on market access and distribution.
Identifies the need for and manages the development and execution of new regulatory procedures and standard operating procedures (SOPs).
Guides and coaches other Regulatory Affairs Associates
Assist in the preparation of special and periodic reports for FDA, such as those required to initiate regulated studies (522 Order)
Provide support for currently marketed products, e.g., review engineering changes, labeling, promotional material, product changes and documentation for compliance and for changes requiring regulatory agency approval.
Qualifications of the Regulatory Affairs – Senior Project Manager
BS degree in Science, Engineering or equivalent, Masters degree preferred
Minimum of 4 year’s regulatory affairs experience
In depth experience with FDA requirements, guidance documents, 510(k) submissions, Medical Device Directive, EU MDR, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards involvement with regulatory submissions, interactions with regulatory agencies (e.g., FDA), and working with cross-functional project teams.
History of successful device submissions
Knowledge of GLP/GCP requirements
Familiarity with regulatory requirements and standards governing global manufacturing and distribution of FDA regulated products;
Detail oriented, high degree of accuracy, deadline driven;
Strong organizational skills with the ability to actively contribute to new projects;
Strong negotiation skills and written/oral communication skills
Ability to multitask, support multiple projects, function on a global basis,
Ability to work independently and under general direction only
Computer skills; MS Office,, MS Project, Adobe Acrobat, Agile
It is the ongoing policy and practice of PENTAX Medical to provide equal opportunity in employment to all employees and applicants. No person shall be discriminated against in any condition of employment because of age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law.
Job posted: 2022-11-07