Regulatory Affairs Manager

Posting Date: 02/07/2019
Closing Date: 02/15/2019
Posting Level: Mid-Level

Osprey Medical, Inc. specializes in the commercialization of proprietary technologies designed to protect CKD patients’ kidneys from the harmful effects of dye. Our proprietary technologies reduce the amount of contrast (dye) used during heart cauterization procedures without compromising X-ray image quality for the physician.

• Our Mission is to improve outcomes in patients with Chronic Kidney Disease by reducing contrast induced Acute Kidney Injury (AKI) and lowering hospital costs.
• Our Vision is to make heart imaging procedures safer for patients with poor kidney function.

We are looking for a Regulatory Affairs & Compliance Manager to join our regulatory team. This person will be responsible for developing, maintaining and monitoring policies, procedures, practices, and activates to assure compliance to all FDA and international regulatory requirements and applicable standards. They will drive efficiency and best practices in the company and support Osprey’s Quality System functions as job allows.
We are looking for a self- motivated candidate with the ability to manage timelines and be a part of a creative and collaborative team. We are looking for a self-starter who likes challenges requiring critical thinking, project management and has keen problem-solving skills. In this role, your work will include activities such as;
• Develop and coordinate regulatory strategy for geographies such as US, EU, UK, Australia and others as required, new product development and internal operational improvement projects.
• Write and submit written content to regulatory authorities: 510K (traditional, 30 days), technical files, change notifications to notified bodies, etc.
• Manage ARTG listing and country specific registrations (such as ANSI, Device Listing, etc.).
• Facilitate demonstration of compliance with internal and external audits. Participate in FDA QSIT, Notified Body Micro and CE/ISO audits. Lead internal procedural auditing program.
• Participate in and approve complaint file reviews.
• Review promotional literature, product labeling, engineering changes, and website content for compliance to FDA regulatory expectations.
• Propose, develop and implement regulatory policies and strategies.
• Manage and maintain FDA small business number.
• Participate in the product development process to assure products are designed in compliance with FDA regulations and applicable international quality systems standards.
• Design, develop and deliver regulatory training to educate internal customers on current and changing regulatory environment and requirements.
• Mentoring/coaching of staff wishing to learn regulatory role.
• Actively participate in team projects.
• Support the QMS by providing compliance expectations, and actively interface with other functional areas on systems development and implementation.
• Other ancillary duties that support the manufacturing processes.

Minimum Qualifications:
• 3-5 years Regulatory Affairs experience in medical device industry (Required).
• Experienced and proficient in dealing with U.S., E.U. and Australian regulatory agencies and guidelines.
• Experience in having direct interaction with governmental bodies.
• Bachelor’s Degree.

Skills Required
• Proficient interpersonal, organization, computer and project management skills.
• Proficient oral and technical file skills.
• Demonstration of sound judgement and thoroughness in regulatory submissions and applications.
• Effective communication and presentation skills.
• Sound decision-making.
• Ability to successfully juggle multiple competing priorities while maintaining attention to detail.

We offer a competitive benefits package that includes:
• Medical/Dental/Vision
• Long-Term Disability Coverage, Life Insurance, AD&D
• Health Savings and Flexible Spending Accounts
• 401k with company match
• PTO and Paid Holidays

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