Job: Regulatory Affairs Manager – US
Ablative Solutions, Inc.
More than 1 billion people have hypertension (high blood pressure). More than half the people treated for hypertension and not able to do not achieve target (control) blood pressure of 130mmHG systolic over 80mmHg diastolic.
Ablative Solutions, Inc. (ASI) has developed propriety technology to treat uncontrolled hypertension
- The Peregrine System™ Kit includes the Peregrine System™ Infusion Catheter (Peregrine Catheter) and Ablative Solutions Inc.’s Dehydrated Alcohol (ETOH).
- The minimally invasive procedure is performed under mild/conscious sedation.
- The Peregrine Catheter is advanced through a small incision in the groin and guided up to the renal arteries using angiography (X-ray with contrast). The system will deliver a small dose of dehydrated alcohol to the region just outside the artery (perivascular space), where the nerves are located, to interrupt the over-signaling of the sympathetic nervous system, that contributes to hypertension; this form of therapy is called alcohol-mediated renal denervation.
The company raised $77 million in capital in January of 2019 to develop the clinical program to obtain the CE Mark and FDA approval for the Peregrine System Kit. The company is currently conducting clinical studies in Europe and the United States to collect data in support of regulatory submissions intended to gain the above approvals and bring this therapy to market.
Position Title: Regulatory Affairs Manager
Reporting Relationship: Regulatory Affairs Management
FLSA Status: Exempt
The Regulatory Affairs, Manager will serve as the regulatory affairs representative on assigned projects for ASI products, supporting both drug product and medical device product. This individual will work independently, and collaboratively with their peers, to generate the necessary documentation and/or justifications to support existing and new product commercial applications as well as represent ASI in related key interactions with regulatory agencies, as appropriate.
• Leveraging working knowledge of US and international pharmaceutical and medical device regulations to provide recommendations and lead activities for project activities to obtain or maintain approvals for clinical and/or commercial products.
• Independently author and compile commercial applications and supporting documentation for medical device applications (510(k), CE marking (MDD, MDR), UK conformity assessment, and other territories), as needed, that meet expected format and content requirements.
• Independently author and compile commercial applications and supporting documentation for drug applications (IND, CTA, NDA, MAA, MA), including supporting amendments, supplements, and annual reports, as needed, that meet expected format and content requirements.
• Ensure a clear understanding of and stay current with pre-approval and post-approval regulations and requirements to identify and support improvements for product, process and quality system, as appropriate. Provide input and direct activities, as needed, to implement changes with quality system and ensure requirements are satisfied.
• Collaborate with peers (within ASI regulatory department, with other ASI departments, and with external consultants) to provide regulatory assessments, oversight and guidance for new product development initiatives or changes to current products. • Collaborate with the project teams to define and generate project-related documentation to support clinical and commercial product, such as quality system documents, design control documents, risk management documents, and labeling.
• Review supporting product documentation to ensure compliance with established requirements and regulatory standards, such as promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
• Complete regulatory assessments for medical device quality system activities, including CAPA, complaints/MDRs, non-conformances, and recalls (health hazard assessments, corrections, removals).
• Maintain current knowledge base of existing and emerging regulations, standards, or guidance
• Complete and/or support the annual assessment of standards and assigned SOPs and ensure
compliance with corporate policies and procedures, as well as established and applicable
healthcare laws and regulations.
• No direct reports, but position will manage external consultants as needed.
• Bachelor’s degree in engineering, biology, chemistry, or health-related discipline.
Experience / Knowledge / Skill Requirements
• 10+ years regulatory experience managing US and/or international regulatory activities for medical device product
• Demonstrated ability to collaborate effectively with cross-functional teams.
• Experience writing and assembling documents and applications for regulatory filings.
• Combination product (drug-device) experience or exposure preferred.
• Working knowledge of medical device and/or pharmaceutical quality systems
• Proficient with Microsoft Office applications, Word, Excel, Project and PowerPoint.
• Demonstrated experience in a fast-paced, entrepreneurial environment.
• Detail-oriented, with the ability to detect and correct errors and/or inconsistencies in a variety of documents.
• Excellent interpersonal skills.
• Ability to work successfully within a team/collaborative environment, with a high level of professionalism.
• Ability to work independently.
Physical Demands and Conditions Requirements
• General office environment.
• Hybrid home office/company office
• Occasional travel may be required
• General office equipment.
Interested candidates should submit their resume and cover letter to: firstname.lastname@example.org