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Senior Specialist, Regulatory Affairs - Remote

LifelancerMassachusetts, Massachusetts, United States

10 days ago

Salary

$86,968.00–$117,406.00 yearly

Job type

Full-time

Remote

Quick Apply

Job description

Job Title : Senior Specialist, Regulatory Affairs - Remote

Job Location : United States

Job Location Type : Remote

Job Contract Type : Full-time

Job Seniority Level : Mid-Senior level

Working Location : NATIONWIDE

Workplace Flexibility : Field

For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling.

Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.

Our five Core Values empower us to achieve Our Purpose :

Patient Focus, Integrity, Innovation, Impact and Empathy.

Learn more about Life at Olympus.

Please note : All correspondence will be sent from our Olympus domain (@Olympus.com). If you receive correspondence from an entity other than @Olympus.com, it is likely not legitimate.

Job Description

The role is responsible for the preparation of submission documents for product registration in selected global markets. The individual acts as an SME in international regulatory affairs and will provide international regulatory expertise in new product developments and sustaining initiatives. Additional responsibilities may include taking part in cross-functional projects, change management, process development, maintenance and mentoring junior staff.

Job Duties

Participate in the preparation and maintenance of global registration dossiers for global market approval. May be designated to support specific regions or key markets as per business need.

Establish effective working relationships with regional counterparts to coordinate, develop, submit and maintain registration submissions and to provide international regulatory support throughout the product’s life cycle.

Liaise with product RA and other stakeholders (e.g. R&D) to support integration of regulatory requirements into product design controls in new product developments.

Support with the interpretation and impact of regulatory intelligence coming from regions within responsibility.

Support maintenance of regulatory files and databases to enable prompt and accurate access to regulatory information for new approvals and renewals.

Support internal and third-party audits of OSTA.

Participate in functional improvement projects.

Provide reports to senior management regarding the status of key deliverables.

Develop and maintain documented regulatory procedures as required to assure consistent and compliant regulatory activities.

Provide support for cross functional initiatives including manufacturing engineering, quality assurance, product development, and clinical affairs as required to assure regulatory compliance.

Job Qualifi

Required :

BS / BA required preferably in engineering or life sciences, or advanced degree and / or other relative experience.

Minimum 5 years prior regulatory affairs experience in the medical device industry. Working knowledge of medical device regulatory requirements outside of the US is preferred.

Excellent written and verbal communication skills

Ability to work in cross-functional teams

Attention to detail

Strong organizational skills

Supervise and mentor junior staff

Previous experience working in a global environment; demonstrated sensitivity to cultural differences

Why join Olympus?

We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture.

Equitable Offerings you can count on :

Competitive salaries, annual bonus and 401(k)

with company match

Comprehensive medical, dental, vision coverage effective on start date

24 / 7 Employee Assistance Program

Free live and on-demand Wellbeing Programs

Generous Paid Vacation and Sick Time

Paid Parental Leave and Adoption Assistance

12 Paid Holidays

On-Site Child Daycare, Café, Fitness Center

Connected Culture you can embrace :

Work-life integrated culture that supports an employee centric mindset

Offers onsite, hybrid and field work environments

Paid volunteering and charitable donation / match programs

Diversity Equity & Inclusion Initiatives including Employee Resource Groups

Dedicated Training Resources and Learning & Development Programs

Paid Educational Assistance

US Only

Center Valley, PA and Westborough, MA

Are you ready to be a part of our team?

Learn more about our benefit and incentives.

The anticipated base pay range for this full-time position working at this location is $86,968.00 - $117,406.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements). Olympus considers a variety of factors when determining actual compensation for this position including : level of experience, working location, and relevant education and certifications.

At Olympus, we are committed to Our Purpose of making people’s lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.

For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.

Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit www.olympusamerica.com.

Olympus is dedicated to building a diverse, inclusive and authentic workplace

We recognize diversity in people, views and lifestyle choices and emphasize the importance of inclusion and mutual respect. We strive to continue to foster empathy and unity in the workplace so that our employees can fully contribute and thrive.

Let’s realize your potential, together.

It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and / or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and / or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.

Applicants with Disabilities :

As a Federal Contractor, Olympus is committed to ensuring our hiring process is accessible to everyone. If you need an accommodation in order to complete the application or hiring process, please contact Olympus via email at . If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-659-6787).

Posting Notes : || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA / RA)

Lifelancer ( https : / / lifelancer.com ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.

For more details and to find similar roles, please check out the below Lifelancer link.

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