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Senior Regulatory Affairs SME (EU Regulations Medical & Pharmaceutical)DallasTexas.

Senior Regulatory Affairs SME (EU Regulations Medical & Pharmaceutical)

Dallas | Texas | United States

Job Title:
Senior Regulatory Affairs SME (EU Regulations Medical & Pharmaceutical)

Type of Position:
DIRECT

Job Location:
Irving, TX (Relocation Assistance Available)

Compensation:
Negotiable

Benefits:
Available (very competitive)

Job Description:
HRU Technical Resources has partnered with a leading chemical and advanced materials company to place a Senior Regulatory Affairs SME (EU Regulations Medical & Pharmaceutical).  This person will:
This person will:
•    Serve as the SME for EU regulations in medical / pharmaceutical / healthcare applications
•    Lead Product Risk Management Reviews
•    Assist customers with regulatory submissions
•    Manage correspondence with regulatory agencies, especially in the EU

Required Knowledge / Skills / Abilities:
•    Strong understanding of EU regulatory framework for medical and pharmaceutical chemical manufacture
•    Proficiency in conducting and documenting regulatory product risk assessments
•    Good understanding of GMP and quality principles as they apply to the medical and pharmaceutical product manufacture
•    Familiarity with US and EU medical device and drug development process (MDD, MDR, 510K, IND, NDA, ANDA)
•    Familiarity with MAF, DMF and eCTD format required
•    Ability to interpret regulations and translate regulatory requirements into compliance strategies
•    Project Management experience; candidates will initially have 3-4 projects going at a time, but as things grow will need to take on more

Desired Knowledge / Skills / Abilities:
•    Ability to manage multiple projects in a fast-paced environment
•    Ability to effectively oversee projects outsourced to consultants/laboratories

Required Years of Experience:
•    Minimum 3 years regulatory / product stewardship experience in medical or pharmaceutical area.
•    5 to 7 years preferred

Education Requirements:
Bachelor of Science in Chemistry, Biological or Life Sciences (biochemistry, toxicology, etc.)

Work Environment / Other Info:
1st shift (day) position, office environment

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HRU has developed a large network of available candidates nationwide, as the company has been providing recruiting and staffing services in up to 22 States for over 25 years. We specialize in engineering, IT, technical and other support services. We are able to recruit and successfully place candidates in job openings in a variety of other fields and positions as well, such as human resources, administration, management, purchasing, sales, customer service, accounting, organic chemistry and more. HRU is able to service clients, regardless of location, by assigning an Account Manager and experienced Recruiters to provide the necessary staffing and support services. Likewise, HRU may assist job seekers anywhere in the United States, regardless of location.

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