The Regulatory Manager will lead or support regulatory activities including strategy development, planning, implementation, and management of all aspects of Regulatory Affairs. This position will support the overall regulatory aspects from global regulatory path submissions to regulatory launch support plus post market regulatory change assessment for multi-platform products. Works closely with cross-functional subject matter experts to ensure an effective partnership and execution of regulatory strategy, regulatory requirements, and the timely submission and approval of global regulatory filings.
Responsibilities and Duties:
· Participates in the planning and prepares regulatory submission documents for FDA and International filings and provides regulatory guidance, or assessment on manufacturing changes and marketing promotional materials.
· Provides expert advice to product development team on regulatory issues as they arise with the development of our current pipeline platforms.
· Leads on selection of Regulatory file compilation and publishing software and systems needed to enable electronic submissions of dossiers to designated global regions.
· Works with third party regulatory consultants as needed for overall company regulatory strategies and relates these strategies to functional areas within the organization.
· Provides regulatory input to support development teams and provide direction on the interpretation and application of regulations and guidance related to devices and combination products.
· Secures and maintains establishment annual licenses, registrations, and listings. Drives International Product Registration projects to completion.
· Plans, prepares, and submits applicable reports and responses to regulatory authorities. Identifies regulatory issues and/or problems and provides resolution and/or appropriate courses of action to management as necessary. Implements resolutions as approved.
· Reviews general internal Quality System compliance to regulations; ensures the appropriateness of regulatory standards referenced within Quality System; and provides regulatory interpretation and makes recommendations designed to improve the effectiveness of the Quality System.
· Assists QA in maintenance of CE Technical Files.
· Maintains Declaration of Conformity when applicable.
· Provides regulatory input for and appropriate follow-up to inspections and audits.
· Monitors current and pending legislation relating to regulatory requirements and assesses new developments affecting the company’s regulatory requirements. Updates internal procedures to reflect new developments affecting the company’s regulatory requirements.
· Reviews and approves domestic and international product labeling, promotional materials, product packaging, and advertising copy. Conducts regulatory assessment for changes to marketed products.
· Prepares reports related to compliance matters.
· Supports risk management activities, as required.
· Manages the compilation of regulatory submissions for foreign and domestic.
· Prepares and participates in design control documentation relating to regulatory requirements.
· Ensures the development strategy meets global regulatory requirements over the lifecycle of the product.
· Manages post market activities including post market surveillance, MDR and Vigilance Reporting, Customer Advisory Notices and Field Actions.
· Monitors the alignment of regulatory strategy with commercial strategy and reports disparities to senior management.
· This list of duties and responsibilities is not all inclusive and may be expanded to include other duties and responsibilities, as deemed necessary.
· Bachelor's degree in Life Sciences or related field or combination of related education and applicable job experience. Regulatory Affairs certification is strongly preferred.
· 5 years of Regulatory Affairs experience in the following areas:
o Progressive experience in the medical device industry, in vitro diagnostics industry desirable
o Demonstrated track record of successful regulatory submissions
o Experience with FDA and EMA required
o Strong working experience with Medical Device Quality Systems
(FDA 21 CFR 820, ISO13485, MDSAP)
o Experience constructing technical files for CE declaration
o Experience with the FDA GI division in CDER/CBER preferred.
o Experience with device or drug device combination products preferred.
· Excellent operational skills including planning, organizing and the ability to deal effectively with a variety of personnel both internally and outside the company.
· Must have demonstrated problem solving abilities and strong organizational skills.
High attention to detail, ability to work on multiple projects with tight deadlines and able to work independently.
Excellent writing, communication, and interpretive skills are essential in this collaborative work environment. An ability to speak to senior management in clear, concise manner is required
Biological Dynamics is an equal opportunity employer.