Principal Product Analyst at Boston Scientific
Remote: Principal Product Analyst Job
Location: Marlborough, MA, US, 01752
Additional Location(s): N/A
Diversity – Innovation – Caring – Global Collaboration – Winning Spirit – High Performance
At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.
*This role can be remote anywhere in the US
About the role:
Provides lead technical and analytical expertise in the management of product complaints in the Endoscopy and Urology divisions. Monitors systems and data to facilitate the appropriate and timely handling of all product complaints per the company’s compliant handling procedure. Ensures compliance with applicable regulations, company policies and procedures.
Your responsibilities include:
- Review complaint communications and assess for regulatory compliance, reportability, and potential impact to patient safety and business operations.
- Serves as internal consultant on regulatory report decision-making. Represents the CMC during internal and external audits. In addition to reviewing approving Medical Device Reports (MDRs), and international vigilance reports, ensures timely transmission to the appropriate regulatory authorities.
- Drives regulatory reporting decisions using event investigation and regulatory decision models. Writes and develops decision models with changes in product advances/therapies to uphold consistent compliance with government mandated regulations.
- Develop and deliver presentations to global regulatory agencies. Topics may include regulatory reporting strategies, compliance issues, or new initiatives such as Global Harmonization.
- Compose written communications detailing the clinical observation, investigation and/or product analysis, and corrective actions, as applicable, to internal and external stakeholders.
- Is an expert on the Post Market staff serving as a resource to promote development of team through helping think out processes, look up information, and direct guidance.
- Minimum of a Bachelor’s Degree
- Minimum of 7 years of related experience
- Hands-on experience in medical device complaint handling preferred
- Familiarity with medical device terminology as well as anatomical and physiological terminology
- Strong proficiency in common computer applications such as Microsoft Office (Excel, Word, and Outlook)
- Excellent written and verbal communication skills are essential
- Must be self-motivated, goal-driven and results-oriented team player
- Critical thinking and good time management skills
Requisition ID: 532875
As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.
So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!
At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.
Boston Scientific maintains a drug-free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.
Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.