ALIVECOR Regulatory Affairs Manager Salary in the United States

Regulatory Affairs Manager

Making the invisible visible. By harnessing the power of artificial intelligence, we’re advancing the practice of medicine for doctors and society. And we’re just getting warmed up.

AliveCor, the creator of the smartphone ECG, seeks a Sr. Regulatory Affairs Representative to join an early stage start-up that is changing the face of mobile health. In this role, you will be part of the regulatory team responsible for proper oversight of medical device development and market introduction. You will work closely with Quality, Engineering, Product Management, Marketing and Sales teams to manage product submissions, perform regulatory pre- and post-market analysis, drive product registrations and listings worldwide, and help implement and maintain an ISO 13485 and FDA compliant Quality Management System. If you have what it takes to drive change in the medical marketplace, then this is the opportunity for you.

Responsibilities:

• Regulatory management:

• Serve as the technical and regulatory interface with regulatory agencies; prepare and review 510(k) submissions, CE Mark technical files and other filings for marketing medical devices in US, EU, Canada and other international markets;

• Filing necessary applications and handling all government interactions pertaining to medical device registrations and licensing in all supported markets;

• Participate with product development teams to develop regulatory plans for new product submissions, coordinate preparation of regulatory documents/reports, make regulatory decisions with the team including developing regulatory justifications letters to file as needed for design and QMS changes; and

• Regulatory review and approval of change order packets.

• Post-market surveillance:

• Review complaints, investigations and closures and determine MDR/MDV filing decisions, as needed;

• Support product regulatory intelligence and risk assessments and updating risk file if needed including review of market product risk trends; and

• Manage all post-market regulatory actions taken for product.

• Drive systemic improvements

• Participate and develop management review;

• Support internal and external audits;

• Maintain and update quality system procedures;

• Maintain quality records and other controlled documents;

• Promote a culture of quality throughout AliveCor; and

• Other Quality duties as assigned.

Requirements:

• 6-8 years’ experience in medical device Regulatory Affairs

• Ability to manage small projects: organized, independent, and results-oriented.

• Superb analytical and excellent communication skills, strong team ethic, and attention to detail

• Preferred:

• Regulatory Affairs Certification from RAPS

• Experience in regulatory affairs for software devices with AI/machine learning algorithms

• Process-oriented thinking

• Handled pre-submissions, 510(k)s and de novo submissions

• Demonstrated competence documenting technical information and communicating it to others.

• BS in STEM or equivalent educational experience pertaining to technical writing, scientific method, and problem solving

The Perks:

AliveCor is located in downtown Mountain View, CA. We are close to Caltrain and supply car and bike parking for employees. We strive to make your life outside work as smooth as possible while you’re at work work, and we offer a long list of benefits to make that happen.

• Competitive salary and competitive stock options

• Flexible and generous vacation policy

• Maternity / Paternity Leave

• 401K

• TriNet medical coverage, employee 100% covered for medical, dental and vision

• Equipment allowance to build out your ideal workspace

• Mobile reimbursement

• Stocked kitchen + weekly catered lunches

• A supportive, collaborative group of people who understand that success depends on the team

AliveCor is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.