Requisition ID: 3516181003
Synthes Power Tools is recruiting for a Sr. Regulatory Affairs Specialist located in Palm Beach Gardens, FL. Synthes Power Tools offers a comprehensive range of air, electric, and battery-driven high and low power instrument systems, including drills, reamers and saws.
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies will offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, we are creating one organization that will be agile and better equipped in today's evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.
The Sr. Regulatory Affairs Specialist manages Anspach's regulatory activities including domestic and international submissions (e.g. 510(k), technical files, design dossiers, global document registration packages), registrations, adverse event reporting, recalls and regulatory assessments. The Sr. Regulatory Affairs Specialist serves as the company's regulatory expert and is responsible for all communications with FDA and international regulatory agencies.
The Sr. Regulatory Affairs Specialist works directly to register products worldwide with primary emphasis on providing support to international distributors and also interacts with regulatory agencies and third parties on all matters of product registrations.
POSITION DUTIES & RESPONSIBILITIES:
· Create, update and maintain regulatory documentation (510(k), EU Technical Files and Class III Design Dossiers, periodic reports, etc.) for submission to the Regulatory Authorities and Registrars in support of market clearance and product licensure and registrations.
· Maintain facility and product registrations for submission to the FDA and international regulatory agencies. Create, update and maintain international document registration packages requested by global distributors on a case by case basis.
· Coordinate and tactically organize documentation for submission of Medical Device Reports (MDRs) to the FDA and Adverse Event reports to international regulatory agencies.
· Manage international recall related activities to international regulatory agencies; follow up reports, and activities needed for recall closure. Create the necessary documentation for the European Authorized Representative to address European regulatory requirements.
· Provide documented regulatory assessments to support new product development and ECRs.
· Provide new product development teams with regulatory guidance for both domestic and global pathways.
· Review new product labels, advertising and promotional literature and marketing claims for regulatory compliance.
· Advise management on changes to regulations, standards, government ruling, and legal stipulations, and insures quality system documentation is updated to reflect such changes.
· Develop and implement procedures for domestic and international regulatory affairs.
· Conduct audits of the quality system to insure compliance with regulatory requirements.
· Keep abreast of domestic and global regulatory trends, laws and movements utilizing regulatory intelligence tools.
· Additional duties as assigned.
· 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.
Ideal candidate profile
· A Bachelor's degree is required. An advanced degree is preferred
· 5 years of professional experience in a regulated industry is required preferable in medical device
· 3 years compliance experience in a FDA regulated healthcare company is required including extensive experience in submissions, FDA communications and international regulatory requirements is preferred
· Knowledge of FDA and global rules and regulations as they relate to medical devices is preferred
· Ability to read, analyze and interpret common scientific and technical journals, financial reports, and legal documents
· Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community
· Ability to effectively present information to top management and peers
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
United States-Florida-Palm Beach Gardens-4500 Riverside Drive
Depuy Orthopaedics. Inc. (6029)