Director, Corporate Compliance - 13969

Job Description: General Summary: Provide strategy and oversight to the Compliance organization within Quality function including the internal auditing responsibilities across all relevant functions within Boston Scientific including R & D, manufacturing, and distribution sites, business units and regulatory, clinical/pre-clinical functions. Facilitate the auditing process to ensure that the Corporation maintains certification to ISO 13485 and Medical Device Directive Requirements.

Assist sites and divisions with external audit readiness, including policy development, best practice sharing, and training/coaching.

Duties and Responsibilities:
?Leads the monitoring of quality assurance systems, policies, processes, procedures and controls ensuring that performance and quality of products conform to established company, international (ISO), and governmental regulatory standards and agency guidelines, and to ensure lasting customer satisfaction.
?Plan and manage the execution of scheduled corporate quality system audits to assess compliance with FDA, ISO, MDD, and internal requirements, encompassing both Medical Device and Pharmaceutical GMP, GCP, and GLP. Develops and implements standards for audit scheduling, investigation and presentation of audit observations, findings and reporting.
?Lead the planning, coordination, and implementation of Corporate audit policies with Corporate and divisional leaders.
?Champion the incorporation of audit findings with Corporate and divisional programs through document reviews, protocol and validation reviews, and training programs, and participation with Corporate and divisional QA on policy/procedure/guideline development.
?Provide training in audit techniques and a government regulations and ISO guidelines.
?Recommend creation and champion improvement in quality systems
?Collaborate with business leaders in divisions, Operations sites and various functions (including Regulatory, Clinical, Pre-clinical) in helping them incorporate regulations and standards into business processes.
?Provides expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies to assure compliance, and then assist the organization in driving implementation
?Encourages problem-solving processes leading to solutions for leverage across divisions, regions and individual sites. Ensure sharing of initiatives/ideas and accomplishments across these same groups.
?Keeps current on changes to all regulatory requirements and facilitates implementation into the Boston Scientific systems.
?Collaborates with multiple cross-functional colleagues to ensure achievement of standards and regulations during product development and commercialization activities
?Coaches, develops and mentors Quality employees. Allocates/re-allocates internal and external resources, as needed
?Participate in succession planning, and the development and implementation of retention strategies of staff. Ensure implementation of functional excellence initiatives.

Job Experience:
Minimum Education & Experience:
Candidate possesses a B.S. Degree with a 10-14 years experience in quality and regulatory for medical devices and pharmaceuticals. 7-10 years of supervisory experience recommended. Significant experience in Compliance Auditing in medical device, pharmaceutical and/or a comparable regulated environment, as well as certified auditor or lead auditor. Experience in Regulatory, Clinical/Pre-clinical compliance is highly desired. An advanced engineering degree or MBA is highly desirable.

Good grasp of FDA protocol and process.

Working Conditions:
General office environment, with potential (domestic and international) travel to BSC facilities for audits and other meetings

Competency Expectations:
?Must be thoroughly familiar with the FDA and CE Marking and the Boston Scientific quality requirements associated with developing products in a regulated industry
?Broad understanding US and International regulations including 21 CFR, 820, 210, 211, and 11 is required.
?Considerable personal experience presenting, interacting, and building effective relationships with regulatory agencies
?Demonstrated success in creating a strategies to lead a team to success
?Excellent communication and presentation skills (articulate and persuasive)
?Pro-active, energetic, self-assured professional with high personal integrity and ability to develop good interpersonal relationships with medical professionals
?Teaches and coaches others in technical and leadership areas.

Searchable Keywords: Director, Corporate Compliance - 13969 / gj-mo

Minimum Education Required: Bachelor

Years of Experience Required: More than 5 years

Expected Travel Time: About 25%

This company may offer relocation assistance.


Boston Scientific offers incredible opportunities to grow and advance, a dynamic work environment and an excellent benefits package. Boston Scientific is an equal opportunity employer, M/F/D/V.