Job Duties and Responsibilities:|
The Regulatory Affairs Specialist is responsible for identifying, evaluating, and ensuring meaningful compliance with all applicable laws, regulations, and standards. Efforts to ensure company compliance shall be inherently established within the company’s Quality System, the Mevion Business Management System. All RA/QA personnel shall seek to develop a quality and results centric company culture that drives employee and customer satisfaction, meaningful regulatory compliance, and continually improving operational excellence.
The Regulatory Affairs Specialist shall ensure continual visibility over the development and promulgation of legal and regulatory enactments identify company improvements or activities necessary to ensure compliance, and ensure that the company establishes controls and/or completes necessary activities to ensure compliance. Further, the Regulatory Affairs Specialist shall also conduct reviews of all and all future target markets to ensure knowledge and fulfillment of establishment registration, device licensing, surveillance, adverse event and corrective action reporting, translation, product standards, and all other requirements necessary to support import, sales, distribution, installation, and support in all chosen distribution markets.
Duties included but not limited to:
Remain aware of new or updated regulations, laws, standards and other official enactments that may apply to the company.
Provide detailed analysis, official recommendations, and gap analyses for new or revised enactments.
Submit medical device adverse and field corrective actions reports and recall notifications.
Ensure adequate compliance schemes associated with all regulatory compliance systems, as required by law.
Author and coordinate all regulatory product clearance submissions and submission materials.
Submit Establishment registration applications. Prepare IDE, 510(k), PMA, CE Mark, and other related regulatory filings.
Represent the company as formal escort or other role in external audits and other regulatory agency interactions.
Obtain and maintain company ISO and CE Certification, as appropriate.
Develop, document, and implement regulatory strategy for new technologies and product modifications.
Interface with FDA and other regulatory agencies regarding regulatory submission strategy and approval reviews, as per company marketing plans.
Establish and maintain a professional and credible image with FDA, and other regulatory agencies.
Assist with formalization and maintenance of other compliance operational subsystems (Privacy/Security, Environmental, Regulatory / Quality).
Establish and implement necessary policies, procedures, templates, and tracking and review mechanisms
Create and deliver employee training, Assist with training record maintenance.
Ensure completion of appropriate systems, mechanisms, and record-keeping.
Conduct internal compliance audits, evaluations, and gap analyses.
Pursue Corrective and Preventive Action, Process Change Control, and Continual Improvement.
Collect and submit data for Management Review.
Support external audits and liaison with pertinent external agencies.
Support and facilitate Business Management System development and compliance.
Minimum educational, training, and experience qualifications:
Bachelor’s Degree in engineering or scientific discipline, or 5-10 years relevant experience in a similar position in a regulated manufacturing environment.
Excellent public speaking, professional writing, typing, and general office application skills are essential for substantial cross-organizational interaction and facilitation, as well as process and record generation.
Minimum 5 years experience working in a regulated manufacturing (medical devices preferred) environment as a Compliance Engineer or equivalent.
Preferred experience with OSHA regulations and compliance systems
Preferred experience with FDA Quality Systems Regulations, ISO standards, information privacy and security, environmental controls, and/or similar compliance schemes.
Excellent English written and verbal communication skills are essential.
Demonstrated leadership ability and excelled professional and ethical demeanor.
Mevion Medical Systems, Inc. offers competitive compensation and benefits.
Mevion Medical Systems, Inc. is an equal opportunity employer.
Location: Littleton, MA
Please submit resume to: email@example.com