Beaver-Visitec International Director, International Regulatory Affairs & Regulatory Operations in Waltham, Massachusetts
A Heritage of Precision, Innovation and Quality
Beaver-Visitec International is focused on developing and manufacturing new, innovative and reliable products for a variety of ophthalmic and specialty microsurgical procedures. Our products are distributed worldwide by sales and marketing professionals recognized throughout the industry for their clinical expertise and outstanding customer service.
Beaver-Visitec International is currently seeking Director, International Regulatory Affairs & Regulatory Operations. As a valued employee of Beaver-Visitec, you will enjoy a total benefits package including competitive salary, medical/dental/vision/life insurance, short- and long-term disability, fitness reimbursement, 401k, and more.
The Director of International Regulatory Affairs & Regulatory Operations will lead operational aspects of international registrations for BVI Class I, II and III medical devices. Collaborating closely with internal stakeholders, the Director will lead and support regulatory strategy and governance activities, ensure that regulatory workflows and processes are adhered to and that regulatory submissions and international registration activities are managed and monitored to meet overall business objectives and applicable regulatory and quality requirements.
This position will be responsible for developing and implementing a global regulatory strategy aimed at expanding registrations of BVI products internationally
Develop strategic direction and priorities for International Regulatory Affairs teams focused on expanding registrations of BVI products globally
Lead governance activities in collaboration with R&D, Marketing and Sales leadership to define regulatory strategy including prioritization of products/geographies based on cross-functional inputs
Oversee and support the planning, implementation and tracking of international registration activities across BVI Innovation Units
Harmonize processes and procedures across BVI Innovation Units and consider future improvements to streamline registration activities
Actively monitor and support registration activities of BVI distributors
Lead the implementation and curate a Global RIM database working closely with BVI Innovation Units, Distributors and internal stakeholders (IT, Supply Chain, Trade Compliance) to ensure data is available in a complete, accurate, and timely manner to support international registration activities
Develop a Regulatory Intelligence capability for target geographies based on the team’s collective experience, publicly available regulatory information and participation in industry conferences and professional associations to inform regulatory strategy and drive international registrations forward with greater efficiency
Required: 10+ years Regulatory Affairs experience in a medical device setting. Experience with Class I, II and III medical devices. Demonstrated experience with major regulatory submissions – PMA, 510(k), etc. Demonstrated experience supporting international registration activities in regions outside of the US, UK and EU. Ability to facilitate, lead and manage the establishment of procedures. Excellent written, verbal, and interpersonal communication skills; able to communicate effectively cross-functionally. Able to adapt to changes in the work environment. Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality. Identifies and resolves problems in a timely manner. Gathers and analyzes information skillfully. Project Management - Communicates changes and progress; Completes projects on time and budget. BS or higher in a technical or clinical discipline (engineering, biology/life sciences).
Preferred: Experience within ophthalmology preferred. Experience obtaining medical device registrations in Australia, Canada, Eastern Europe, Middle East, Africa, Latin America and Asia Pacific. Master’s degree in technical or clinical discipline.
Sitting for long periods of time; standing; squatting; reaching; computer work (typing), phone usage; filing; lifting up to 20 lbs. unassisted.
Beaver Visitec International is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.
External Company URL: www.beaver-visitec.com
Street: 500 Totten Pond Road 10 City Point