Regulatory Affairs Associate II

Planet Pharma; Irvine (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Planet Pharma is seeking a Regulatory Affairs professional to lead device regulatory strategies and submissions. The role collaborates with RA, R&D, and Operations to influence product development and lifecycle management.

Responsibility includes filing regulatory applications and managing authority interactions for products requiring approvals. The candidate will review protocols and manufacturing changes, with a focus on EU MDR 2017/745 requirements and Class IIb device experience across

Qualifications

• Experience building regulatory submissions and responding to health authority questions.
• Experience with Class IIb (EU) medical devices and EU MDR 2017/745 knowledge.
• 3–5 years of direct regulatory affairs experience; advanced degree may be required.
• Experience submitting changes/renewals and authoring submissions outside the US (JAPAC, MEAR, LATAM).
• Strong ability to influence peers and manage cross-functional teams.

Responsibilities

• Prepare device regulatory strategies to enable first-pass approvals under limited supervision.
• Develop and manage content strategies for regulatory submissions (INDs/CTAs, amendments, new market apps).
• Represent RA during product development and lifecycle management discussions to influence teams.
• File necessary regulatory applications and manage government interactions for regulated products.
• Review study protocols/reports and validation protocols/reports for compliance.
• Review and approve manufacturing changes for Class IIb devices (EU).

Skills

Regulatory strategy

Content strategy

Stakeholder management

Negotiation

Regulatory submissions

Documentation review

Manufacturing changes review

Education

Advanced degree

Job description

• 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.