Attorney in Alameda, CA

In-House

Alameda, CA

Attorney in Alameda, CA

Non-practicing Attorney

4-5 yrs required

No

Job Title: Regulatory Affairs Manager – APAC - Diabetes Care (on-site)

Job Responsibilities:
- Manage a team of regulatory specialists to oversee the Diabetes Care product portfolio in the APAC region.
- Develop and advance the organization's policy and procedures for regulatory affairs and compliance to establish a compliant culture.
- Represent Regulatory Affairs on cross-functional project teams, providing strategic input and technical guidance on regulatory requirements in the APAC region for Diabetes Care projects.
- Utilize technical regulatory skills to propose strategies on complex issues.
- Work closely with in-country regulatory representatives to compile, prepare, and review medical device or IVD submissions to regulatory agencies in the APAC region.
- Provide strategic input and technical guidance on regulatory authority queries.
- Evaluate proposed design and manufacturing changes for regulatory impact and implement required regulatory actions.
- Anticipate regulatory and related obstacles and emerging issues throughout the product lifecycle.
- Oversee processes involved with maintaining annual licenses, registrations, listings, and patent information.
- Ensure compliance with product post-marketing approval requirements.
- Review product labeling and promotional materials to ensure compliance with relevant regulatory requirements.
- Provide regulatory support for internal and external audits.

Education and Experience Information:
Required Qualifications:
- Bachelor's Degree OR an equivalent combination of education and experience.
- 4-5 years of experience in a regulated industry (., medical products, nutritionals).
- 2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
- Strong verbal and written communications with the ability to effectively communicate and present at multiple levels in the organization.

Preferred Qualifications:
- Bachelor's Degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields.
- Masters in a technical area or MBA; PhD in a technical area or law.
- 5+ years of experience in regulatory affairs.
- Supervisory experience.
- Scientific writing experience.
- Working knowledge of ISO and EN standards, as well as country-specific standards in the APAC region.
- Strong working knowledge of regulatory requirements for the APAC region.
- Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).

Salary Information:
The base pay for this position is $112, – $224,. In specific locations, the pay range may vary from the range posted.