BD (Becton, Dickinson and Company) Senior International Regulatory Affairs Specialist in Warwick, Rhode Island
Job Description Summary
BD Interventional’s Surgery worldwide business unit, located in Rhode Island, is a leading developer, manufacturer, and marketer of innovative, life-enhancing medical technologies. For the past 40 years, we have stood out as the market leader in providing solutions in soft tissue reconstruction including products for hernia repair, specialized surgical procedures, fixation and biologic implants. In addition to this extensive suite of products, our BioSurgery business is delivering a growing line of enhanced sealants and hemostatic products to complement surgical techniques across, thoracic, cardiovascular and other surgical specialties.
Our company has a strong tradition of developing our employees to learn, grow and excel. We are continually building our team with qualified, team oriented individuals to enhance the success of our company.
The Surgery business unit is situated in a central location, surrounded by a scenic coastline with easy access to T.F. Green Airport, AMTRAK Train Stations and Route 95, a major highway connecting to Providence, Connecticut, Boston and New York City within a short amount of time.
The Senior International Regulatory Affairs Specialist is responsible for writing, supporting, and assisting in gaining approval of product registrations and other submissions to International Business Centers (IBCs). This position entails development of submissions in conjunction with other BDI Surgery departments, requiring working knowledge of products under review and of relevant regulations and guidance documents.
Provide international regulatory support through the product life cycle on product project teams (e.g., developing regulatory strategies, timeline development, change control and preparing submission related documents.).
Provide general support for international regulatory team and projects, as needed.
Coordinate the generation and maintenance of product International Dossiers and all related supporting documentation for international product registrations.
Supply International Dossiers and other related information (e.g. Certificate to Foreign Government, etc.) to BDI IBCs; help coordinate and respond to inquiries from BDI IBCs through use of various internal systems, in order to facilitate new product registration, design change notifications, license renewals, and international marketing tendering and reimbursement processes.
Research and respond to regulatory questions received from other division functions and outside sources (i.e., distributors, customs issues, etc.).
Coordination, review, and submission of product labeling for marketing outside the United States.
Manage key internal systems, databases, and records.
Understand the company’s products, surgical techniques and the use of implants and other devices.
Special projects as assigned.
Education & Experience
Bachelor's degree required, with an understanding of healthcare industry.
Minimum 5-7 years of international regulatory experience with medical device registrations (including CE Design Dossiers, Technical Files, and International Dossiers), and knowledge of compliance to international harmonized standards and international regulations (such as US FDA, MDD, Japan, Canada, Australia, Latin America and Asia Pacific).
Knowledge, Skills & Abilities
Experience working with international businesses or cultures.
Good oral and written communication skills – ability to work on cross-functional teams.
Must have technical writing skills and be proficient at compiling successful submissions for the appropriate audience.
Self-motivated by working independently and having the ability to take ownership of his/her responsibilities, the capability to work under time pressure, and to organize diverse projects in a timely manner.
Ability to interact proactively and provide counsel and expertise to internal and external customers.
Working knowledge of electronic documentation and information systems.
Ability to travel approximately 10% of time.
Primary Work LocationUSA RI - Warwick
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status