Regulatory Affairs Associate II

Planet Pharma; Irvine (CA); On-site; USD 45,000 - 59,000; Full time

Job summary

Planet Pharma is seeking an Regulatory Affairs professional for a device-focused role based in Irvine, CA. The position collaborates with internal and external partners to deliver regulated medical devices to patients, with a focus on EU submissions and global variations.

Responsibilities include strategy development, cross-functional engagement, and timely government filings while ensuring compliance with EU MDR 2017/745.

Qualifications

• Experience supporting new device submissions and variations in global regions (non-US).
• Recent experience with Class IIb medical devices and EU submissions/renewals.
• Knowledge of EU MDR 2017/745 and regulatory expectations.
• Proven track record of authoring submissions and obtaining approvals for Class IIb devices.
• Ability to leverage extensive experience and judgment to influence cross-functional teams.

Responsibilities

• Prepares device regulatory strategies enabling first pass approvals with limited supervision.
• Manages content strategy for regulatory submissions (INDs/CTAs, market applications, variations).
• Represents RA Device on product development and life-cycle teams to advise peers.
• Filing of required applications and handling government interactions for regulated products.
• Review/approval of engineering study protocols and manufacturing changes for Class IIb devices.

Skills

Regulatory affairs

Medical devices

EU MDR

Submission strategy

Education

Advanced degree

Job description

Target PR Range: 33-43/hr DOE

This Regulatory Affairs Device role will be based in Irvine, CA and works with internal and external partners in order to deliver products to patients.

Responsibilities:

• Prepares device regulatory strategies that enable first pass approvals under limited management supervision. Develops and manages content strategy for regulatory submissions, including INDs/CTAs and amendments, new market applications and supplements/variations with limited management supervision.
• Builds and maintains relationships within the Regulatory Affairs functional areas and the Operations and Research & Development (R&D) organizations.
• Represents RA Device on product development and life-cycle management teams to negotiate, influence, and provide strategic advice to peers in RA, R&D, and Operations.
• Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.
• Review/approval of engineering study protocols/reports and validation study protocols/reports.
• Review and approval of manufacturing changes for Class IIb (EU) medical devices.

Qualifications:

• Experience supporting new device submissions, license renewals and variations (based on manufacturing site proposed changes) in countries outside of US, such as JAPAC (Singapore, Malaysia, Hong Kong, Vietnam), MEAR (S Africa, Botswana, and other African countries), LATAM (Brazil, Mexico).
• In addition, there should be experience in responding to health authority questions satisfactorily due to submissions/renewals/variations.
• May require an advanced degree and 3 to 5 years of direct experience in the field.
• Recent experience with Class IIb (EU) medical devices;
• Proven successful track record of authoring/submission/approval of Class IIb variations/renewals; knowledge of EU MDR 2017/745 regulation.
• Relies on extensive experience and judgment to plan and accomplish goals. Performs a variety of tasks. A wide degree of creativity and latitude is expected.

Experience Level = 3-5 Years