Clinical Regulatory Specialist Jobs in California

Outstanding customer-focused and account management skills.

Become an expert at understanding the Healthcare Partner’s unmet needs related to the management and protection of closed surgical incisions.

Effectively communicate the clinical, ease-of-use and cost-savings benefits of NPseal® compared to traditional dressings and NPWT competitive offerings.

Develop and manage relationships with Key Customer decision-makers including Physicians, Nurses, decision makers, and Operating Room staff.

Manage travel and expenses per approved budget and timelines.

Other responsibilities as necessary to perform position.

Crisis Management: Assist in handling product-related crises or recalls, coordinating efforts to address safety concerns and regulatory issues promptly.

Bachelor's degree in a relevant field, such as Regulatory Affairs, Product Management, or a related discipline.

Product Documentation: Manage and organize product documentation, including specifications, testing reports, and certificates, to support compliance efforts.

Labeling and Packaging: Review and approve product labeling, packaging materials, and marketing materials to ensure they adhere to regulatory requirements.

Knowledge of relevant regulations and standards in the industry, with a strong focus on product safety and compliance.

Strong attention to detail and organizational skills.

Completes forms and generates all reports necessary to comply with regulatory requirements and institutional policies.

Establishes and maintains research files and documentation pertaining to regulatory requirements for clinical research/clinical trials.

May provide training and education to other personnel.

Participates in required training and education programs.

Five (5) years minimum of directly related experience; 2 years of regulatory experience and 3 years of clinical research experience.

Ability to identify areas of project interest and connect with appropriate support group: CCTO SPIN, IRB, Tech Transfer

Proficient in Microsoft Word, EndNote, Adobe Acrobat, Acrobat Plug-ins, Document Management Systems, Excel, StartingPoint templates

Manage the regulatory activities log tracking annual and current submissions

Direct publishing experience a plus

Knowledge of the regulatory archival, records and submissions systems with demonstrated ability to learn new systems and processes.

Experience in preparing INDs, CTAs, NDAs, BLAs and MAAs

Excellent writing skills (e.g., English usage), a keen attention to detail, and strong verbal and interpersonal communication skills

Experience in clinical trials operations, knowledge of clinical trials regulatory requirements, or experience working with an IRB.

Knowledge, Skills And Abilities (required)

Bachelor’s degree and three years of related experience or a combination of education and relevant experience.

Manage and oversee new study initiation process, including educating study staff and sponsors, resolving issues and providing regulatory guidance and support.

Excellent communication skills and superb attention to detail.

Experience with MS Office products and database applications required.

Incredible company culture and proven management team

MS WORD knowledge with WORD styles to format various documents for regulatory submissions

ECTD publishing experience with using eCTD software to produce a compliant electronic submission

3+ years of Regulatory Proofreading/Publishing experience within biopharma, medical device, IVD, or CRO industries (protocols, amendments, IBs, CSRs, INDs, NDA modules)

QC experience is a plus

REMOTE | Regulatory Publishing/QC opportunity with a well-funded Rare Disease biotech