Regulatory Affairs Sr Manager (Medical Device)

Job Title: Sr. Manager Regulatory Affairs
Salary: $180-$195K (15% bonus)
Location: Westford, MA 01886
Duration: PERM
Hours: M-F 8:30am-5:30pm (flexible)

Job Summary
Responsible for collaboration, design, and implementation of the worldwide regulatory strategy for all products.
Essential Duties and Responsibilities
The incumbent may be asked to perform other function-related activities in addition to the below-mentioned responsibilities as reasonably required by business needs.

• Responsible for the oversight of Regulatory Affairs as directed.
• Plans, analyzes, and prepares regulatory submissions for FDA and may support other international agencies as necessary. Manages the collection and coordination of information to prepare regulatory documentation packages for review and submission to regulatory agencies, subsidiaries or to commercial partners.
• Plans, prepares, and manages timelines for assigned regulatory tasks including, but not limited to initial submissions, meeting requests, protocol assistance, etc., ensuring that timings are supportive of the corporate goals.
• Leads the effort to support new product development and provides submission requirements for gaining market approval in the US and worldwide as necessary.as part of the design controls process. Supports the development and assessment of regulatory requirements for clinical and preclinical programs to assure all development activities are following applicable regulations and guidelines.
• Reviews document and product changes for regulatory submission impact and carries out necessary change notification submission requirements as required.
• Reviews labeling, promotional materials, and training materials for regulatory compliance.
• Maintains State Licenses, Registrations and other certifications as required to maintain regulatory and product approval compliance. Manages the compilation materials for license renewals, updates, and registrations.
• Understands and communicates US and OUS regulation requirements. Actively reviews new laws/regulatory requirements to maintain proficiency in worldwide regulations and communicates information to management.
• Complete activities as Person Responsible for Regulatory Compliance (PRRC) for
• Provides regulatory review of documentation prior to submission for any external agency or customer, as required.
• Interfaces with regulatory agencies as appropriate.
• Responsible for review of customer complaints for reportability to regulatory authorities and reporting to FDA and other regulatory agencies, as appropriate
• Oversees correction and removal activities.
• Participates in development of Regulatory Strategy documents for new/improved products as required.
• Participates on project teams or sub-teams for the planning of activities needed to meet long term corporate objectives.
• Maintains RA library, Submissions, Changes and documentation in hard copy and electronic files. Creates and maintains a calendar of regulatory applications and renewal dates.
• Provides reports on RA submission progress/activities and various other key tasks to Executive leadership.
• Analyzes available information, exercises sound judgment, and makes appropriate decisions in a timely manner.
• Provides supervision to reporting regulatory professionals including assignment of tasks and deadlines, performance appraisals and professional development.
• Tracks by country and product which countries have met regulatory requirements.
• Work with operations to ensure product specifications meet regulatory requirements.
• Monitor and ensure both compliance with and documentation of compliance with ’s policies and procedures as outlined in various Company policies, including the Global Approval Authority Matrix and other mandatory policies pursuant to one’s job description.
• Embody and deliver the “Exceptional Everyday”.

Qualifications (Select the minimum qualifications required for this position to successfully achieve business requirements)
Education
? Bachelor’s degree required.
? Master’s degree preferred.
Specific Area of Study: BA/BS in life sciences or engineering
Experience
? 12+ years relevant experience in Medical Device industry and direct regulatory experience
Specific Related Experience:
Skills

• Requires experience with complex regulatory submissions for Medical Devices (510K, IDE), regulatory experience with active devices with software is strongly preferred.
• Experience with international device regulations required.
• Requires initiative, creativity, problem-solving ability, and superior oral and written presentation skills.
• Demonstrated project management experience.
• Regulatory Affairs Certification preferred.
• Ability to develop and maintain positive relationships with domestic and international contacts working in regulatory capacities within the government and other organizations.
• Demonstrated successful experience in registering Medical Devices in the US and internationally and managing Regulatory Affairs function within Medical Device industry.

Physical Demands
The physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• ? Sit; use hands to finger, handle or feel objects, tools, or controls.
• ? Stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl.
• ? Other (please specify) 10% travel may be required.