We are working with an award winning specialty surgical company seeking a Regulatory Affairs Manager.
The Regulatory Affairs Manager will manage the Regulatory Affairs department and across the organization. This position is primary responsibility for assembling regulatory documents for review by the regulatory affairs management. Strengths in this position would be in Domestic and International, Product Registration and Medical Device Class 1 and 2 and the knowledge of the different process.
Understand, support and follow the Corporate Vision, Mission & Values Statements.
Support company goals and objectives.
Understand, follow and support Mizuho OSI's internal Quality System policies, procedures and work instructions including but not limited to applicable external regulations (21 Code of Federal Regulations Part 820 Quality System Regulations and applicable International Standards).
Under the direction of the Director, Regulatory Affairs compile, prepare, review, and submit regulatory submission documents for the company in the U.S. as well as internationally including but not limited to Device Master files, technical files, annual reports, amendments, supplements, etc.
Gather and assemble information necessary for submissions in accordance with regulations and relevant guidelines.
Maintain regulatory database of regulatory information and submissions.
Review, recommend and present regulatory policies, methods, SOPs, protocols, reports for regulatory compliance and report on findings to assure adherence to FDA and global requirements.
Assist regulatory management and teams in the implementation and delivery of regulatory documentation.
Participate in Mizuho OSI regulatory training courses and current trends to stay up to date with relevant laws, regulations and guidelines on medical devices developments.
Develop rapport within and across the company regarding regulatory matters.
Maintain and develop timelines for regulatory submissions, and correspondence for company sponsored projects.
Follow general instructions to complete projects, plan and organize workday to complete time sensitive assignments.
Under the management direction, maintain the Device Manufacturing licenses as required and mandated by the state and/or other regulatory agencies.
Assist regulatory management and subject matter experts in the coordination of briefing documents and responses to requests or questions from government authorities or other entities.
What you will need to be successful in this role:
International, Product Registration and Class 1 and 2 Registration
People Management Skills
RA Developing Strategy
EXPERIENCE AND EDUCATION REQUIREMENTS:
Requires 8-10 years of experience in the Medical Device industry.
Bachelor's degree in business or related field; or equivalent combination and experience.
Excellent oral and written communication, interpretive and interpersonal skills, including time management skills.
Strong attention to detail.
Knowledge of 21 CFR and FDA guidelines (GMPs).
Ability to work on multiple tasks to meet company requirements.
Demonstrated ability to coordinate and work effectively with cross-functional teams.
Excellent Computer Skills - MS Word, Excel, Power Point
Medical Device experience required.
For immediate consideration apply today!