23 days old

Regulatory Affairs Associate - Carpinteria, CA OR Radnor, PA

Kelly Services
Carpinteria, CA 93013
**Regulatory Affairs Associate / Sr. Regulatory Specialist - Carpinteria, CA OR Radnor, PA**

**Job Summary:** The Sr Regulatory Specialist ensures company's Federal and State compliance related to the storage, sale and distribution of FDA related materials, includes but is not limited to, medical devices and pharmaceuticals for the Americas (US & Latin America). In addition, this position acts as the key interface for the Corporate Regulatory Affairs Organization to provide FDA and other related agency regulatory guidance and regulation interpretations that impact the Americas business. Keeps informed of regulatory regulations & changes and implement the necessary changes to maintain company compliance.

**Job Duties and Responsibilities** (Listed in order of importance):

+ Keeps current on FDA & state pharmacy regulations and evaluates their impacts on company's International business, propose guidance, procedure implementation, programs & policies.

+ Responsible for maintaining company's compliance for sale, storage, and distribution of regulated products (includes pedigree requirements).

+ Coordinates & participate in agency inspections/audits and responds to applicable agency requests.

+ Assists sales team and customers with questions pertaining to regulation requirements.

+ Responsible for the development & maintenance of related SOPs.

+ Prepares and presents training material to company associates.

+ Maintains applicable master data coding for regulated products.

+ Applies for and renews federal and state licenses, including Board of Pharmacy requirements.

+ Responsible for product reviews & classification accuracy.

+ Performs other duties as assigned.

**Job Requirements:**

+ Bachelor's degree, preferably in a science related field

+ 5-8+ years regulatory experience in medical device or pharmaceutical industry

+ DEA knowledge and clinical experience a plus

+ Demonstrates a thorough knowledge of FDA regulations, ICH Guidelines, Drug Quality and Security Act, Pedigree, Adverse Event Reporting, cGMP, GDP and Sunshine Act

+ Board of Pharmacy (BOP) and Verified- Accredited Wholesale Distributor (VAWD) knowledge

+ Strong interpersonal skills, required to talk to customers, suppliers and company associates

+ Good analytical and problem solving skills.

+ Good organizational skills

+ Strong computer skills including Word, Excel and Access

+ SAP knowledge a plus

**Physical Demands/Work Environment (Under Typical Positions):**

+ Typically works in an office environment with adequate lighting and ventilation and a normal range of temperature and noise level.

+ Travel up to 10% of time.

+ Work assignments are diversified. Examples of past precedent are used to resolve work problems. New alternatives may be developed to resolve problems.

+ A frequent volume of work and deadlines impose strain on routine basis.

+ Minimal physical effort is required. Work is mostly sedentary but does require walking, standing, bending, reaching, lifting or carrying objects that typically weigh less than 10 lbs.

**_Apply Today! For more information contact_** Airika at 562-206-2707 or

**Why Kelly** **** **?**

With Kelly, youll have access to some of the worlds highest regarded scientific organizationsproviding you with opportunities to work on todays most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits youll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your careerconnect with us today.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. at


Posted: 2019-10-21 Expires: 2019-11-21

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Regulatory Affairs Associate - Carpinteria, CA OR Radnor, PA

Kelly Services
Carpinteria, CA 93013

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