Our client is developing precision delivery platforms for the treatment of neurological and oncological disorders. They are seeking a Regulatory Affairs Manager (Contractor) who can provide day-to-day execution for regulatory submissions and compliance requirements. Reporting into the Senior Director of Regulatory and Clinical Operations, you will be responsible for the development and management of regulatory activities for their medical device and drug/device combination programs. This is a hybrid (onsite/remote) position in the Boston area and local candidates are preferred. This engagement will be 20-25 hours per week for about 6-8 months.
Responsibilities:
- Take direction, lead, and execute regulatory activities and responsibilities for all domestic and international submission work (IDE’S, PMA’s, 510(k)’s, CE Design and Technical Dossiers, etc)
- Work with management to identify, analyze and communicate new or changing regulatory requirements to the company and its impact on the business.
- Perform eMDR submissions to FDA for all MDR reportable events/circumstances.
- Work with members of the regulatory team to ensure regulatory submissions are completed on time and according to the associated requirements.
- Work with Product Development, Marketing, Clinical Operations, and other departments as needed to ensure that all product labeling, instructional and promotional materials are in compliance with regulatory requirements.
- Support All MDR related activities and requirements
- Actively comply with company’s Quality System. Support the development of the Company’s quality objectives and will work in conjunction with the company employees to ensure ISO/QSR compliance.
- Participate in regulatory and quality audits as required to maintain ISO/QSR compliance.
- Perform all administrative activities associated with the department. This will include supporting the department’s goals and objectives.
Qualifications:
- Bachelor degree in a life science. Advanced degree (MS, PhD, etc) preferred.
- Minimum of 5+ years of experience in a Regulatory Affairs for medical devices and drug-device combination products.
- Regulatory experience in Class III devices and drug/device combination products required.
- Must have Class III IDE/PMA experience. Master Access Files (MAF), eMDR reporting, 510(k), EU Tech File and De Novo Filings a plus.
- Experience with drug-device combination device products.
- Experience and understanding working with US FDA, European (MDD and MDR), and Global regulatory authorities (ex: Japan PMDA). Understanding of said regulatory requirements.
- Must be flexible and comfortable with ambiguity in a small company environment.
- Successful management of relationships at all levels of the organization
- Excellent verbal and written communication skills.
- Team-oriented individual with strong interpersonal skills. Excellent organizational skills, and a good blend of discipline and creativity.
- Solid analytical skills and the ability to problem solve quickly.
- Commitment to company with ability to function within a small start-up environment.
- Skilled in Microsoft Office (Word, Excel, PowerPoint, Project, and Outlook).
- Makes good decisions in a timely manner, based upon a mixture of analysis, wisdom, experience, judgment and direction.
- Orchestrates multiple activities at once to accomplish a goal, uses resources effectively and efficiently; is able to adjust in light of change and shifts gears comfortably.
Note: All contractors must be authorized to work in the United States. H1B sponsorship is not available.