Specialist, Regulatory Affairs
Our company provides final assembly, labeling and packaging services of drug delivery devices to the pharmaceutical and biotechnology industries and soon clinical fill finish capabilities. Scientist and Engineers work closely with our partners to continuously create and introduce innovative, patient centric, solutions to enhance patient compliance and user experiences. Dedicated project managers work closely with their counterparts at the partner company to develop and maintain program timelines in line with the strategic and business needs of our partners. In addition, for those partners who wish to have SHL handle the final assembly process, SHL Pharma offers robust final assembly and labeling capabilities that enable our partners to improve speed to market and reduce the number of parties involved as well as have one clear point of responsibility.
- Provide leadership and submission strategy in the preparation and filing of CMC sections of regulatory submissions and interactions with regulatory agencies (directly or with customers) for Pharmaceutical/ Device Combination Products.
- Collaborate with cross-functional team to support customer filing strategy and manage regulatory activities and timelines for investigational and commercialized products.
- Lead and coordinate the timely compilation and critical review of the CMC data package from other functional team representatives to provide complete and appropriate documentation that supports agreed world-wide registration timelines.
- Provide CMC regulatory guidance to project teams and Global Regulatory team.
- Experience with Device Design Controls and Risk Management Processes.
- Medical device product development and manufacturing experience covering several regulatory specialty areas of concern: device registrations, 21 CFR 820 quality system requirements, new product development, etc.
- Knowledge of FDA’s QSR, GMP’s, ISO13485, EU Medical Device Directive 93/42/EEC (and all applicable amendments);, ISO regulations/standards, including ISO 13485, 10993, 14971
- Serve as Regulatory Affairs representative on assigned New Product Development teams and related technical task forces.
- Must possess Bachelors in Engineering or Science, Minimum 5 years of experience in Regulatory Affairs with strong medical device product development and manufacturing experience covering several regulatory specialty areas of concern: device registrations, quality system requirements, new product development, design controls, etc.; experience in direct interaction with mainly domestic but also international Regulatory Agencies
- Experience in analyzing and developing strategies for regulatory submissions and compliance issues
- Knowledge of FDA’s QSR, GMP’s, ISO13485, CMDR, Medical Device Directive 93/42/EEC (and all applicable amendments);, ISO regulations/standards, including ISO 13485, 10993, 14971
- Ability to liaise, negotiate and interact with FDA and worldwide regulatory agencies; orchestrate meetings and teleconferences, document interactions between SHL Pharma and FDA
- RAC certification and auditing experience in accordance to FDA QSR, ISO 13485 a plus, but not required.
- Competent using office software including MS Word, Excel, Internet Explorer, PowerPoint, and Outlook.
We have an excellent benefits package and offer a salary that is based on experience and accomplishments. If you possess the required experience and qualifications and want the challenge of growing with our company then submit your resume in confidence to our Human Resources Department at RecruitUS@shl-group.comApply for this job