The Senior Regulatory Affairs Program Lead is responsible for regulatory activities to support new, modified and currently marketed medical devices. 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 role is also responsible for: the review and approval of all device labeling and product support information used in the promotion and educational activities of Synthes products for compliance to global regulations and company policies and procedures.
- Represent regulatory affairs on product development teams by attending team meetings and providing the global regulatory plan, regulatory assessments and regulatory decisions.
- Prepare regulatory documentation for devices, including IDE, 510(k), PMA, Technical File and Design Dossier documentation for submission to regional Health authorities. This includes the resolution of regulatory issues and questions from regulatory agencies during the pre-market product development phase.
- This person will engage regulators, when necessary, in oral and written communications to discuss pending or new submissions, regulatory requirements, etc.
- Assist in the preparation of approval documents to support rest of world registrations, such as EU CE marking activities, as required. Additional activities may require notarization and legalization of documents, and requesting of Certificates to Foreign Government and Free Sale Certificates.
- Review engineering changes to currently marketed products and prepare internal regulatory assessments for documenting decisions to submit or not to submit in accordance with relevant regulations and guidance.
- Review 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.
- Assist with the maintenance of the regulatory database with accurate and current regulatory information.
- Maintain 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.).
- Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.
- Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.
- Provide assistance and guidance to junior staff members, as well as provide routine regulatory information to associates and affiliates. This position may have supervisory responsibilities for one or direct reports in Regulatory Affairs.
- Review and provide regulatory authorization related to ongoing product design changes and field action investigations.
- Provide Regulatory Affairs support during internal and external audits.
- Plan schedules for regulatory deliverables on a project and monitor projects through completion.
- Perform other duties as assigned.
- A minimum of a Bachelor’s 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 be considered.
- Knowledge of US FDA and EU MDD/MDR regulations and guidances is required. Knowledge of G9 country regulations is preferred.
- Knowledge of orthopedic 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.
- Excellent written, verbal communication and presentation skills are required, including the ability to communicate clearly, succinctly and effectively over the phone and in writing.
- Experience presenting at FDA meetings is preferred.
- Solid interpersonal skills including the ability to remain calm, professional, diplomatic, and positive are required.
- Ability to work as a member of a team in a timeline-driven environment with limited supervision is required.
- Being detail-oriented while having the ability to handle multiple ongoing projects/tasks is required.
- Experience in supervising, mentoring, or training other personnel is preferred.
This position will be located in West Chester, PA and may require up to 10% travel, including some light international.