Senior Regulatory Affairs Specialist
Senior Regulatory Affairs Specialist
Posted on :
18-05-2025
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1 Vacancy
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Job Description
AliveCor seeks a Senior Regulatory Affairs Specialist to join this exciting startup 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 postmarket 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.
Role & Responsibilities
- Collaborate and execute regulatory strategies for US Europe and other global registrations
- Participate in preparation and review of global regulatory submissions
- Support government/FDA interactions pertaining to medical device registrations and licensing;
- Participate in the development of regional regulatory strategy and update strategy based upon regulatory changes;
- Assist in the review of advertising and promotional materials;
- Provide regulatory support to crossfunctional product development and project teams throughout the product lifecycle;
- Support or lead regulatory activities required for US FDA EU MDR NMPA PMDA ANVISA compliance;
- Support worldwide resellers and distributors with product registrations and renewals;
- Provide regulatory assessment for manufacturing and design changes;
- Provide regulatory review and approval of change order packets;
- Support or lead product regulatory intelligence and risk assessments;
- Assist in maintaining compliance with product post market requirements;
- Support postmarket regulatory actions taken for the products;
- Support internal and external audits;
- Ensure compliance with internal procedures and external regulations and standards;
- Maintain regulatory and quality records and other controlled documents; and
- Promote a culture of quality throughout AliveCor
Requirements
- Bachelors degree in Science Engineering Math or medical field or equivalent educational experience pertaining to technical writing scientific method and problem solving
- 4 years of experience in medical device Regulatory Affairs
- Experience in regulatory affairs for software devices with AI/machine learning algorithms (SaMD)
- Participated in the preparation of presubmissions 510(k)s or de novo submissions
- Experience with and knowledge of EU Medical Device Regulations
- Ability to manage small projects: organised independent and resultsoriented
- Superb analytical and excellent communication skills strong team ethic and attention to detail
Preferred candidate profile
- Advanced degree or Regulatory Affairs Certification from RAPS
- Processoriented thinking
- Supported or lead international submissions (preferably in AsiaPacific and/or LATAM)
- Demonstrated competence documenting technical information and communicating it to others
Perks and benefits
We strive to make your life outside work as smooth as possible while youre at work and we offer a long list of benefits to make that happen.
- Hybrid working model
- Flexible and generous vacation policy
- Maternity / Paternity Leave/ Adoption/ Commissioning leave
- Generous Medical Benefits Above market family floater medical insurance coverage including both parents or in law parents
- Metro connectivity from office
- 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 other classification protected by federal state or local law.
Required Experience:
Senior IC
Employment Type
Full-Time
Department / Functional Area
Key Skills
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