About this role
Job Description
The Sr Director, Regulatory Affairs position is responsible for managing and providing strategic and tactical direction for Regulatory Affairs activities company wide. Design and implement regulatory strategy through cross-functional engagement and management of a team of RA professionals. Job duties:
- Drives implementation of and continued compliance to global regulatory requirements and interpret and applies pertinent laws and regulations governing company products to meet business objectives.
- Leads development, implementation and maintenance of regulatory processes at a company-wide level.
- Leads worldwide regulatory submissions for Class II and Class III medical devices.
- Support the Regulatory Affairs leadership in developing regulatory strategies and application of the strategies to align with the business plans for a particular product.
- Actively works with R&D, Clinical Research, Marketing, and Quality to ensure appropriate planning, tracking, and alignment of contents and timelines for regulatory submissions across indications for US and International regulatory submissions.
- Serve as main contact with US Food and Drug Administration (FDA) and liaises with Regulatory Agencies in other countries when needed, directly or in coordination with local country representation.
- Demonstrate sound understanding of related fields (e.g., manufacturing, product /process development, quality assurance, etc.) and the ability for diverse problem solving.
- Monitors the regulatory environment regionally/globally and provides assessments for the impact of new and changing regulations on the company’s areas of interest. Ensures new regulations or changes to existing regulations are communicated throughout the organization through company policies, procedures, and training.
- Leads representation of Regulatory on project teams and partners with the cross functions on the team to ensure alignment of regulatory strategy and plans with the team objectives.
- Support and contribute io editing/revising Standard Operating Procedures.
- Develops and supports training for global regulatory processes and system implementations.
- Builds team cohesiveness by leading, influencing, mentoring and motivating team members.
- Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization
- Performs additional responsibilities as assigned.
Qualifications
- Minimum BA/BS degree in a scientific or technical discipline or other relevant field of study.
- Minimum fifteen (15) years of professional regulatory experience in medical devices.
- Minimum seven (7) years of management or leadership experience/responsibility.
- Knowledge of medical device regulations, trends and developments impacting company operations and products worldwide.
- Hands-on experience with 510(k), PMA and Technical File/Design Dossier submissions (PMA experience is essential).
- Experience interfacing with relevant regulatory authorities through all stages of device life cycle.
- Excellent verbal and written communication skills.
- Proficient with MS Word, Excel, Outlook, and Teams.
Desired Qualifications
- Master’s degree desired.
- Effective facilitation skills to motivate multi-functional groups and proven effective leadership skills to guide and mentor team members.
- Demonstrated ability to work effectively with a variety of work groups including multi-national teams to assure conformance to regulatory requirements, internal processes and procedures.
- Excellent interpersonal communication, collaborative teamwork, and negotiation skills.
- Demonstrated project management and organizational skills.
EEO
We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, national origin, gender, age, religion, disability, sexual orientation, veteran status, marital status or any other characteristics protected by law.
Fair Chance Ordinance
If you are applying to perform work for Terumo Neuro in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Terumo Neuro reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.
Terumo Neuro will consider for employment qualified job applicants with arrest or conviction records in accordance with the California Fair Chance Act, Los Angeles County Fair Chance Ordinance for Employers, Fair Chance Initiative for Hiring Ordinance, and San Francisco Fair Chance Ordinance.