Regulatory

Job Summary:
Manage international regulatory submissions, registrations, and compliance, ensuring timely coordination and project management within the medical device industry.

Job Requirements:

• Minimum 3 years of direct experience in international registration

• 4-5 years as an independent Regulatory Affairs (RA) specialist in US/EU/Global registration

• Proficiency in time management and project management

• Experience with global regulatory strategies and collaboration with RA teams in different regions for product registration

• Familiarity with medical device design control processes and coordination with design/manufacturing sites for additional documents required by global regulations

Job Responsibilities:

• Coordinate and prepare document packages for regulatory submissions, internal audits, and inspections

• Lead or compile all materials required for submissions, license renewals, and annual registrations

• Recommend changes to labeling, manufacturing, marketing, and clinical protocols for regulatory compliance

• Monitor and improve tracking/control systems for regulatory submissions

• Stay updated on regulatory procedures and changes, ensuring compliance with global regulations

• Interact with regulatory agencies on defined matters, providing necessary documentation and responses

• Recommend strategies for obtaining the earliest possible approvals of clinical trial applications
  
  

Pay: 40-60

Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client.

Pay Details: $40.00 to $60.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

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The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.