Proclinical is partnering with a leading management consulting firm to advertise a vacancy for a Senior Regulatory Affairs Program Lead position. The organization, which prides itself on its leading presence as a global advisor of talent supply chain strategies and workforce solutions, is seeking for a driven and talented individual to join its Pennsylvania-based office. This is an exciting opportunity to work for an international company and bolster a career in the clinical field.
The Senior Regulatory Affairs Program Lead will be responsible for regulatory activities to support new, modified, and currently marketed medical devices in the line of products. This includes the preparation of regulatory documentation for submission to regulatory authorities (e.g., IDE, 510(k), PMA, Technical File and Design Dossiers) or internal regulatory assessment documentation. The Lead will also be responsible for the review and approval of all device labeling and product support information used in the promotion and educational activities of products for compliance to global regulations and company policies and procedures.
Job Responsibilities:
- Representing regulatory affairs on product development teams by attending team meetings and providing the global regulatory plan, regulatory assessments, and regulatory decisions.
- Preparing regulatory documentation for devices, including IDE, 510(k), PMA, Technical File, and Design Dossier documentation for submission to regional Health authorities; resolving regulatory issues and questions from regulatory agencies during the pre-market product development phase.
- Engaging regulators, when necessary, in oral and written communications to discuss pending or new submissions, regulatory requirements, etc.
- Preparing approval documents to support rest of world registrations, such as EU CE marking activities, as required; Additional activities may require the notarization and legalization of documents and requesting Certificates from Foreign Governments and Free Sale Certificates.
- Reviewing engineering changes to currently marketed products and preparing internal regulatory assessments for documenting decisions to submit or not to submit in accordance with relevant regulations and guidance.
- Reviewing product labeling and product support information for currently marketed products to ensure that product information and claims are consistent with premarket clearances and approvals and in compliance with relevant regulations and guidance.
- Assisting with the maintenance of the regulatory database with accurate and current regulatory information.
- Maintaining current knowledge to ensure compliance to the applicable regulatory and corporate standards/requirements (FDA Quality System Regulations, European Quality Standards, ISO 9001/13485, MDD, IMDRF, etc.).
- Providing assistance and guidance to junior staff members, as well as providing routine regulatory information to associates and affiliates.; this position may have supervisory responsibilities for one or direct reports in Regulatory Affairs.
- Reviewing and providing regulatory authorization related to ongoing product design changes and field action investigations.
- Providing Regulatory Affairs support during internal and external audits.
- Planning schedules for regulatory deliverables on a project and monitor projects through completion.
Skills and Requirements:
- A minimum of a Bachelors Degree is required; biomedical engineering or other engineering/science degree is preferred.
- A minimum of 7 years of regulatory experience is required. Individuals with an Advanced Degree and a minimum of 5 years of regulatory experience will also be considered.
- Knowledge of US FDA and EU MDD/MDR regulations and guidance is required. Knowledge of G9 country regulations is preferred.
- Knowledge of orthopaedic implants is preferred.
- Practical experience in a medical device Regulatory Environment is required; preparing US & international submissions for medical devices and a successful track record is required.
- Experience with pre-submissions, IDEs, and/or Class III devices (PMA or HDE) would be beneficial.
- Design Dossiers and Technical Files experience is preferred.
- Experience interacting with US FDA is required.
- Experience presenting at FDA meetings is preferred.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Maya Smith at +267-405-6995 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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