Director, Regulatory Affiars

This is a significant position for a growing medical device company in AnnArbor. If you are interested and feel you qualify, apply directly to Colin -contact info below.
Colin WattsDirector of OperationsIndustrial Partners Group, LLC43260 Garfield, Suite 250
Clinton Township, MI 48038
586-416-2894, x. 107
586-703-3179 cell
cwatts@ipgllc.us
Title Director, Regulatory Affairs - Class III (Implantable) Medical DeviceIndustry
Location: Ann Arbor, MI
Salary: 110,000 (low) to 165,000 (top); $140,000 mid-point.
Bonus: 20% annual (paid quarterly)
Benefits: Comprehensive medical/dental/vision; 401(k) w/ companymatch;
Company funded pension. Generous vacation program. Paid relocation available--------------------------------------------------------------------------
Description
a.. Provides instruction, direction and coaching to Regulatory Affairspersonnel regarding operational philosophy/procedures.
b.. Manages Regulatory Affairs personnel hiring activities, andtraining for new personnel. Cooperatively manages resource allocations forproduct development, sustaining production, and quality improvementprojects.
c.. Maintains current knowledge of global medical deviceregulations, acts as consultant to other departments, participates indecision-making concerning policies, regulatory requirements and strategies,and manages external consultants as needed.
d.. Defines information and actions needed to meet requirements,prepares documents and/or submissions required to obtain clearance orapproval from governmental agencies for global commercial distribution ofproducts.
e.. Guides and supports acquisition and partnership developmentprojects with attention to due diligence and subsequent regulatorycompliance.
f.. Maintains good compliance standing with regulatory andcertifying agencies. Coordinates clinical study activities to assurecompliance and value.

Selected responsibilities:
1. Maintain and follow proper compliance and quality systemrequirements.
2. Analyzes, evaluates, verifies and organizes information/data andwrites/prepares documentation and submissions for the purpose of obtainingclearance/approval for legal market distribution.
3. Communicates and works in conjunction with other internal andexternal entities to provide regulatory consultation and/or obtaininformation for document preparation.
4. Defines projects information required to meet the regulatoryrequirements for marketing/distribution applications, quality systemscompliance and clinical studies of existing, new or proposed products.
5. Actively participates in decision-making concerning departmentalpolicies, determines regulatory requirements and strategies for legaldistribution of medical products and in the selection of external results.
6. Maintains current knowledge of global regulations pertaining tolegal distribution of medical products and provides training to internal andexternal persons.
7. Management duties: Provide guidance/training to RA personnelregarding operational philosophy/procedures, manage RA personnel hiringactivities, manage training of new personnel, manage project allocations,and manage individual projects.
8. Maintains documentation, reference databases, and historicalrecords.
9. Participates in industry task groups.