Senior Project Manager, Regulatory Affairs
Lead or Provide on-going support to core and project teams for regulatory issues and questions. Find, interpret and apply regulations and guidance appropriately for situations. Provide business and product information to enable development of strategies and requirements and communicate that information to the product development teams. Provide regulatory support for currently marketed products as necessary. This includes reviewing labeling, promotional materials, training materials, changes to existing devices and documentation. Support Operations with product import/export requirements. Manage recall activities with FDA and other Pentax affiliates. Prepare submissions and reports for regulatory agencies as required. Complete understanding and wide application of technical or regulatory principles, theories and concepts. General knowledge of other related disciplines. Negotiate directly with the FDA or other international agencies, as needed. May supervise subordinate RA Associates with dotted line reporting structure. Lead projects to develop and implement documented regulatory affairs processes. Participate in the development of general strategies, including how to interact more effectively with government agencies and agency personnel, including submissions and audits. Develop and implement solutions for maintaining Regulatory Affairs product files to support compliance with regulatory requirements. Work under general supervision following established procedures. Represent PENTAX in providing industry input to proposed rule-making by Health Authorities. Keeps current on global directives, harmonized standards and procedures and communicates changes that may affect cross functional areas. Provide training and support to other members of the department. Reviews regulatory publications to keep apprised of new regulatory developments.
- RA representative on the R&D cross functional team
- Sets regulatory strategy and identifies standards and target country regulations for the design team
- Review Engineering changes including registration impact, risk assessments and review and approve engineering change orders and project documentation in MasterControl and Agile
- Regulatory Process Owner for Digital Asset Management of Claims Collateral including supporting timely review and release of Advertising/Promotion material
- Prepare regulatory submissions, technical files and international product registration documents as needed.
- Regulatory support for business systems including ERP change management (Form 239).
- Maintain SAP Trouble Code List
- Facilitate all FDA registration and listing related activities
- Manage interactions with US Customs and Border Control and ensure compatibility and compliance with customs documentation requirements.
- ACE Index Support for Import and Export
- Manages Global Product Offering Index including resolving OUS shipment request hurdles
- Manage all Recall/Field Action Activities
- Support to Post Market Surveillance Reports
- File/obtain Export Certificates from FDA for C2 and SVS Products
- Support International product registrations
- Review and approve all Adverse Events Reportability Determination forms to ensure timely review of all complaints for MDR reporting
- BA and/or BS degree in Science, Engineering or equivalent, Master’s degree preferred
- RAC preferred
- Minimum of 5 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;
- Excellent communication, interpersonal and time management skills;
- Displays Leadership skills in a matrix environment
- Flexibility in the ability to prioritize, multi task, and learn quickly with a positive attitude.
- Strong negotiation skills and written/oral communication skills
- Strong organizational skills and time management skills
- Ability to multitask, support multiple projects, function on a global basis, prioritize, conduct team meetings, and meet project deadlines
- 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.
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Job posted: 2021-02-09