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Regulatory Affairs Specialist IV


Location: Andover, Massachusetts
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The Regulatory Affairs Specialist will develop and implement regulatory strategies, focused on Orthopedic products and on achieving compliance with the upcoming European Medical Device Regulation. The Regulatory Affairs Specialist will be responsible for providing regulatory input and strategic direction for upgrading existing technical files and ensuring that new product are also compliant to the new requirements. Current business-critical projects include: product rationalization (part number reduction), revision and upgrading of existing Design History Files and other regulatory documents, transfer of product registrations between companies and strategic planning to ensure optimal business continuity.

ESSENTIAL DUTIES AND RESPONSIBILITIES
• Using a broad base of knowledge and understanding of regulatory requirements, this person helps lead a focused team to ensure that the product portfolio and the required regulatory documentation is optimized for our International business.
• Evaluates regulatory issues, develops regulatory strategies and revises technical documentation for upcoming regulatory submissions for orthopedic products.
• Develops US and International regulatory strategies and verification and validation activities for assigned product submissions
• Actively assists with our upcoming audits and certification reviews with Notified Body (BSI).
• Maintain Regulatory Affairs product files (design dossiers, periodic regulatory reports) to support compliance with regulatory requirements)
• Reviews promotional and advertising material for adherence to approved product claims.
• Works in partnership with Product Development, Manufacturing and QA/QC to ensure overall compliance with European and International regulations.
• Coordinates roll-outs of product changes with corporate and international regulatory teams.
• Ensures timeliness of regulatory submissions according to business needs. This includes ensuring prompt follow-up to the questions and requests received from regulators.


DESIRED MINIMUM QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Any equivalent combination of education and experience that provides the applicant with the knowledge, skills, and abilities to perform the job is acceptable.

• EDUCATION

Bachelor’s degree in science or other technically related field, or equivalent work experience.


• TYPE AND NUMBER OF YEARS OF EXPERIENCE

• Minimum of 5 years regulatory experience with increasing responsibility in a medical device or pharmaceutical company, or familiarity with orthopedic product development in a technical role.
• Experience in working effectively with cross-functional teams; especially with manufacturing sites.
• Experience with orthopedic or implantable products is preferred, but not required.
• Awareness of business strategies and tactics, including an understanding of regulatory impact.
• Must have proven ability to prepare and submit documents to regulatory agencies.
• Ability to explain regulatory requirements and pitfalls to project teams and colleagues.
• Can communicate existing facts in an organized and clear manner to cross-functional teams.
• Must be detail oriented, well-organized and able to work both independently and in teams.
• Must possess and demonstrate an understanding of FDA, MDR requirements and quality system requirements.
• Demonstrated sense of humor, and the capacity to enjoy working in a great team.

• SKILLS
• Must have strong writing, project management and communication skills.
• Demonstrated skills in contributing to multiple projects simultaneously.
• Awareness of business strategies and tactics, including regulatory impact.
• Can communicate facts in an organized and clear manner to cross-functional teams.
• Established skill in objective thinking.
• Provides regulatory input to cross-functional teams.
• Brings proposals for solutions to identified issues.
• Develops plans to meet pre-defined Regulatory goals.
• Responsible for tasks and simple submission components, based on templates
• Ability to explain regulatory requirements and pitfalls to project teams and colleagues.
• Capability to interact with diplomacy and tact while maintaining appropriate assertiveness.
• Willingness to take ownership and accept responsibility for actions and decisions.
• Must be detail oriented, well organized and able to work both independently and in teams.
• Ability to communicate effectively in both informal and formal settings.

• CERTIFICATION
Regulatory Affairs Certification (RAC) is a plus, and can be obtained on the job.

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