Provide technical and administrative regulatory support to ensure timely introduction of new products subject to medical device and combination product regulations in U.S. and global regions. Provide regulatory support to marketed products and ensure company’s regulatory compliance status.
Essential Duties and Position Responsibilities
Maintaining regulatory data base, including establishment registration and FDA FURL and GUDID data base
Support labeling UDI data entry and maintenance
Maintaining international registration license data base and support international RA requests
Prepare and submit applications to the FDA for marketing of new/modified medical devices (e.g., 510(k)
Support in determination of the appropriate regulatory submission requirements and strategies for new or modified products. Prepare required documentation as needed (e.g., No 510(k) Rationales, international change notifications).
Coordinate review of FDA submissions and test protocols with Corporate Regulatory, Medical and Legal Departments, and respond to any questions posed by these departments or the FDA.
Prepare application documentation for international marketing approvals (i.e. CE Mark Technical files and Dossiers, JSTD, International Dossier).
Assist Product Development and Quality Assurance in planning pre-clinical studies and bench testing that will ultimately be used in regulatory submissions.
Assist in the review of proposals for clinical design validations, clinical field trials and customer preference tests.
Represent regulatory affairs on product development teams to provide direction with respect to regulatory/clinical requirements and strategy.
Assist in development of new product instructions for use/promotional material. Review product labeling for compliance with medical device regulations and Division/Corporate Policies.
Provide marketed product regulatory support for change management activities, product registrations, and business improvement activities.
Support due diligence and business integration activities as assigned.
Support the development and implementation of regulatory processes, procedures, and standards as assigned.
Qualifications, Knowledge, and Skills Required:
Knowledge and experience (minimum of 1-2 years) with regulatory requirements for medical devices (510(k)’s, CE mark technical files, international registrations).
Good oral and written communications skills - analytical thinking and technical writing; ability to work on cross-functional teams; ability to manage several parallel deliverables.
Working knowledge of statistics and electronic documentation and information systems.
Ability and desire to travel as needed.
Additional Salary Information: competitive
Internal Number: 2019-1320
About Beaver-Visitec International, Inc.
Beaver-Visitec International, Inc. (BVI) is a highly regarded ophthalmic device manufacturer offering a broad range of single use instruments and custom procedure packs. The corporate headquarters are located in Waltham, MA. BVI provides innovative and high quality products that perform consistently and predictably for surgeons. Our brands are considered standard of care in most ophthalmic specialties. Our global sales and marketing professionals are known for their clinical expertise and ability to build collaborative surgical partnerships. This enables our business to consistently develop and provide new and innovative solutions that address current and future unmet clinical needs.