Senior Regulatory Affairs Specialist

JOB DESCRIPTION:

Req 6103-1 - Sr Spec, Regulatory Affairs

Duration - 9 Months

Location - Irvine, CA 92606

Max Pay - $45.00-$51.30/hour

Summary:

The main function of a Regulatory Affairs Specialist is to complete and maintain regulatory approvals and clearances of assigned products.

Key Responsibilities:

* Create regulatory submissions (exercising judgment to protect proprietary information) for finalization and submission by OUS EW affiliates; track timelines and document milestone achievements, participate in developing regulatory strategy, prioritize submissions with operating plans as well as ensuring alignment with KOD in countries (e.g., OUS, [the globe minus US, EU, Canada]).

* Participate in providing guidance on strategies and contingency planning with respect to OUS regulatory requirements, including assessing impact of proposed and current global regulations and proposing suggestions for expediting approvals.

* Participate in representing the OUS regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving conflicts between those requirements and development issues, and/or reporting to management.

* Participate in providing guidance and feedback to business unit regulatory teams on registration requirements for new and renewal registrations, product and process changes, and review of labeling content? and guidance on process improvement projects, based on prior experience and responses from affiliates.

* Other incidental duties assigned by Leadership.

Additional Skills:

* Coursework, seminars, and/or other formal government and/or trade association training required

* Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel

* Good written and verbal communication skills and interpersonal relationship skills

* Good problem-solving, organizational, analytical and critical thinking skills

* Solid knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices

* Solid knowledge and understanding of global regulatory requirements for new products or product changes.

* Solid knowledge of new product development systems

* Strict attention to detail

* Ability to interact professionally with all organizational levels

* Ability to manage competing priorities in a fast paced environment

* Must be able to work in a team environment, including inter-departmental teams and representing the organization on specific projects

* Ability to build productive internal/external working relationships

* Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

Education and Experience:

* Bachelor's Degree or equivalent in scientific discipline (e.g., Biology, Microbiology, Chemistry)

* 5-7 years of experience required

Qualifications:

• Regulatory affairs experience with Class II and III medical devices. Outside of the US experience is preferred on top of domestic experience, specifically the EU.
• Proven track record of developing written RA plans & strategies.
• Familiarity with the medical device FDA/EU MDR submission process.
• Class II or II medical device

All qualified applicants will receive consideration for employment without regard torace, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status.We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.