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Manager, Regulatory Affairs
We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further — Haemonetics is your employer of choice.
Responsible for directing activities to ensure compliance with global medical device and in vitro diagnostic regulations. Will initiate, develop and implement all phases of regulatory strategy to ensure necessary approvals for company products/services, with focus on Class 2 devices. Provides regulatory authorities with appropriate documentation in the aim of obtaining marketing authorization. Establishes and maintains relationships with external partners, and regulators.
- Developing regulatory strategies and assessments for life cycle management activities including product changes, design/manufacturing changes, process changes and obsolescence
- Planning, prioritization, and coordination of global registration activities (EMEA, CIS, LATAM, APAC) interfacing with the international in-country teams
- SME & submission responsibility for US and Canada including amendments, 510k, & recalls. Support of CE marking and technical file maintenance and reviews.
- Support of audits and regulatory reviews, including Notified Body interactions
- Maintenance of internal regulatory information and data
- Provide input/data to regulatory department metrics and KPIs
- Ensures a global regulatory team approach through RA collaboration
- Identify and implement process improvements and updates to regulatory department SOPs, training, communication
- Manage and develop regulatory personnel to meet established goals
Strong technical knowledge of medical device products, including in vitro diagnostics
Bachelor’s degree, preferably in a scientific or technical discipline
IVD Experience Required.
Minimum 7 years’ experience in the medical device industry, including in a FDA Quality System and ISO 13485 environment, with experience in regulatory affairs
Position can be based in Boston, MA or fully remote in the United States.
Occasional domestic and international travel
Conditions of Employment: Haemonetics’ policy requires COVID-19 vaccination for all U.S. employees, unless approved for a medical, religious or business exemption. While we recognize employees have their own individual beliefs and perspectives regarding vaccination, we believe it is an important step as part of our obligation to protect our colleagues, our customers and our communities as we continue to make health and safety our top priority.
Learn more here
Job posted: 2022-07-10