Regulatory Affairs

**Medical Device experience preffered, but would consider pharmaceutical or biotech background**



REGULATORY AFFAIRS SPECIALIST

PRIMARY FUNCTION:

The Regulatory Affairs Specialist (RAS) will report to the Director for Regulatory Affairs A RAS plans and coordinates submissions and other document packages for tissue, medical device and combination products into worldwide regulatory agencies. The RAS works with worldwide business partners to recommend strategies for earliest possible approvals of governmental applications. He or she compiles all material required for worldwide submissions, license renewals, and annual registrations, and applies scientific principles to understanding safety and efficacy on a wide range of products. The RAS participates as regulatory team member on design and investigation projects. He or she monitors and improves tracking and control systems and keeps abreast of global regulatory procedures and changes. The Senior RAS will provide greater support to the group by taking on more projects of greater complexity under limited supervision.

DUTIES AND RESPONSIBILITIES:

• Maintain a professional stature and confidentiality.
• Follow all departmental and company policies and standard operating procedures.
• Prepare and submit, or support the submission, technical file and Design Dossiers for new and modified medical devices, tissue products and combination products through interface with worldwide regulatory agencies, notified body, physicians, consultants and internal team members.
• Participate in product development teams to insure US and other worldwide regulatory requirements are incorporated as part of the development process.
• Interpret existing and or new regulatory requirements as they relate to company products and procedures. Communicate regulatory requirements to appropriate personnel.
• Communicate any FDA, International and Industry correspondence on submissions, technical files and Design Dossiers to appropriate teams and RA management.
• Assist in post market activities. Support, R&D, Marketing and Operational Teams in regulatory assessment of proposed product changes or product transfers.
• Review product labeling and advertising materials for compliance to US and International regulations.
• Establish and maintain regulatory information systems and label systems both electronically and hard copy.
• Review and approve change management documentation.
• Prepare and update US and International product listings, registrations, certificates and licenses.
• Participate on CAPA teams.
• Maintain electronic and paper files and documentation to support RA activities.
• RA and QA project and management support as directed.

Additional Responsibilities - Sr. RAS:

• Act as company representative in developing and maintaining positive relationships with worldwide reviewers.
• Address and advise RA Management and teams on appropriate pathways to market.
• Lead Investigation and other CAPA team assignments.


WORKING RELATIONSHIPS:

Internal:

o Daily Interaction with all internal departments.
o Regular interaction management employees.
o Periodic interaction with senior management as appropriate.

External:

o Works with various regulatory, international and industry agency representatives.
o Contact with outside vendors as required.
o Trade associations and related organization interaction as appropriate

EDUCATION:

Specialist I, II Bachelors Degree in engineering or BA/BS in Life Sciences, Nursing, Medical Technology or related discipline.
Senior Specialist Masters or other advanced degree in Life Sciences, Nursing, Medical Technology or related discipline.

EXPERIENCE AND OTHER REQUIREMENTS:

• Experience:

Specialist I 0-2 years RA or QA experience in the Medical Device, Pharmaceutical
or Life Science industries.
Specialist II 2-5 years RA, QA or Clinical experience in the Medical Device,
Pharmaceutical or Life Science industries.
Senior Specialist 5 years or greater RA or Clinical experience in the Medical Device,
Pharmaceutical or Life Science industries. Must have direct experience
in 510(k) submissions and extensive knowledge of FDA and/or
international regulations.
• Experience in sterile, implantable products preferred.
• Bilingual in English with Asia Pacific or Spanish languages a plus.
• Excellent interpersonal skills overall, with an emphasis on both oral and written skills.
• Self motivated with a proactive attitude and the ability to work independently.
• Able to react to situations with a “sense of urgency”.
• Excellent organizational skills with attention to detail.
• Project management skills a plus.

resumes in .doc format to:

sharper@hire-source.com
www.hire-source.com

**please include salary requirements**

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