Director of Regulatory Affairs- Simply Biotech

OVERVIEW

Are you looking for a new career opportunity with an exciting biotech company?! Then we've got the right team for you! In this role, you're responsible for the duties listed below.

Immediate opening for a Director of Regulatory Affairs with a biopharmaceutical company in Aliso Viejo, CA who possesses:

• Understanding of clinical evaluations, specifically the ability to read and update Clinical Evaluation Reports (CERs).
• Experience with EU MDR.
• Experience with Class III devices; implantable or ophthalmic devices is highly desired.
• Minimum of 7 years of experience, though consideration for those with 7-10 years who have managed or held senior positions will be given.

Email resumes to aaron@simplybiotech.com or call 858.427.3668

FULL DESCRIPTION: Reporting to the SVP, Clinical and Regulatory Affairs, the Director, Regulatory Affairs will collaborate in the development and implementation of world-class regulatory program for the company technology and product offerings. Key responsibilities will include preparation, analysis, and submission of dossiers to various governing agencies in support of business growth.

The selected candidate will be responsible for:

• Preparing international regulatory submissions and FDA submissions which may include Technical Documents, Technical Files, Device License Applications and Amendments, and PMAs
• Identifying and gathering data needed to support filings, responses to inquiries, and registration maintenance to enable commercialization of products that are developed, manufactured, or distributed to meet relevant global regulatory requirements
• Responsible for creation and annual update of Clinical Evaluation Report including State of the Art and Subject Literature Review
• Key contributor responsible for the preparation and review of regulatory submissions consistent with US and OUS regulatory requirements and guidelines and assures complete and timely response to Health Authorities during application review
• Serve as a subject matter expert on regulatory affairs and provide training and guidance to team members, as needed
• Author and/or review regulatory procedures and update as necessary
• Strong understanding of regulatory requirements for medical devices, including FDA regulations (e.g., 21 CFR Part 820, 21 CFR Part 11), ISO standards (e.g., ISO 13485, ISO 14971), and international regulatory frameworks
• Excellent communication skills and ability to collaborate effectively with cross-functional teams
• Participate on cross-functional project teams and act as global regulatory advisor
• Review technical documentation for suitability to support regulatory applications
• Maintain superior knowledge of competitive technologies in addition to medical and technical developments related to the company's products

The selected candidate will also possess:

• This role requires strong experience with premarket regulatory activities in the US, EU and other global markets.
• Proven track record of successful regulatory submissions and interactions with regulatory agencies (FDA, Notified Bodies, etc.).
• Ability to thrive in a fast-paced environment
• High integrity and character and be a person who is tough minded, fair and principled.
• Creative technical skills that lead to innovative approaches to the development process.
• Effective analytical and problem-solving skills with the ability to apply creative solutions to challenges.
• The ability to establish priorities and build enthusiasm for projects while encouraging individual innovation and creativity.
• Solid project management skills to handle multiple projects and set/manage timelines with a high degree of urgency.
• Self-confidence and be decisive with excellent communication skills in both oral and written formats, as well as excellent listening, presentation and problem-solving skills.
• The ability to interface effectively with all levels and functions within the organization.

Salary Range: $190k-220k/yr

For immediate and confidential consideration, please email your resume to aaron@simplybiotech.com or call 858.427.3668. More information can be found at www.simplybiotech.com