Senior Regulatory Affairs Specialist

Job Title: Sr Regulatory Affairs Specialist
Location: Santa Clara, CA 95054-2807
Duration: 12 Months
Work Arrangement: Hybrid (Onsite – 4days/week)
Pay Range: $70 - $75 per hour (W2)

We are seeking a “Sr Regulatory Affairs Specialist” to join one of our leading healthcare clients.

Description:
Senior Regulatory Affairs Specialist (International)
The Senior Regulatory Affairs Specialist (International) is to provide support for the regulatory department to ensure efficient and compliant business processes and environment. The individual may execute tasks and play a consultative role by partnering across business functions. The individual may assist in identifying data needed, obtaining this data and ensuring that they are effectively presented for the registration of products worldwide. The individual may prepare and submit documentation needed for registration worldwide or may oversee such preparation.

Years Experience:

• Minimum 3 years 3-4 years experience in a regulated industry (e.g., medical products, nutritionals). 2-3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. 
• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.) 

• Have working knowledge in EU MDR
• Have working knowledge in Regulatory Change Assessment in
• Have working knowledge in US and EU medical device submissions
• Have experience supporting internal and external inspections
• Work cross-functionally and in a matrixed environment
• Have experience with continuous improvement activities

• Bachelors Degree in Related field OR an equivalent combination of education and work experience 
• Masters Degree In Regulatory Affairs preferred and may be used in lieu of direct regulatory experience. 

Duties:

• Manage and oversee the preparation of high-quality global filings for sustaining changes and new product registration. Manage rest of world (all geographies outside the US and EU) submissions. 
• Strategic Planning: Assist in SOP development and review. Provide regulatory input to product lifecycle planning. Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions. Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes. 
• Assist company SME’s to interpret existing or new regulatory requirements for company products and procedures, labeling, marketing projects, testing and record keeping. May anticipate and advise on future regulatory trends and direction and recommend preemptive approaches for company regulatory. 
• Proactively track global regulatory requirement changes and work with Global Strategic Intelligence (GSI) team to disseminate the information to all team members.

We are looking for the candidate who are eligible to work with any employers without sponsorship.

If you’re interested, please click “Apply” button.