Director Of Regulatory Affairs

Senior Regulatory Affairs Leader for a CRT, Electrophysiology MedTech Company – Marlton - New Jersey (US)

Metric Search is currently partnered with a market leading company that has developed a first-of-a-kind MedTech device - CRT, Electrophysiology piece of equipment. The company's ultimate aim is to successfully treat heart failure patients. This exciting company is looking for an experienced and motivated individual to join the Team in Marlton - New Jersey.

About the company

• The device delivers electrical pulses
• Global company presence
• Recently received multimillion dollar funding
• FDA approved MedTech device
• Developed a device to treat patients experiencing moderate to severe CHF symptoms, even after appropriate treatment

What the role offers

• Opportunity for growth
• A great benefits package

Responsibilities (Not Exhaustive)

• Regulatory contribution to design control activities for existing and new products
• Ensure that domestic and international regulatory filings assigned meet regulatory requirements.
• Create project plan, manage timelines and priorities on all submissions
• Prepare and submit regulatory submissions to obtain approval to conduct domestic and international clinical investigations and to seek regulatory approval to commercialize the new products and their accessories (IDE supplements, PMA, Annual reports, change notices, etc.).
• Maintenance of technically related regulatory documentation for existing products
• Review existing product regulatory documentation and ensure at least an annual update of technically related regulatory
• Monitor Engineering Change activities
• Determine timelines for regulatory filings.
• Creation and submission of new product regulatory submission documents
• Identify and resolve regulatory/quality issues throughout the product development process
• Manage technical file documentation for international approvals in multiple geographies.
• Working knowledge of standards and regulations as outlined in the QMS documentation and structure.

Requirements

• Be based in New Jersey or be nearby for Onsite working
• Electrophysiology or related life science experience
• Experience with Regulatory Affairs, with primary responsibility for preparing regulatory submissions for Class III devices
• An electrical or biomedical engineering degree
• Implantable device experience

If you meet the following criteria, then you would be a great fit for this role!

If you want to make the next step in your career, then click ‘Apply’ above, or feel free to send over your CV to [email protected].