Jobs and Careers

Senior Regulatory Affairs Manager, Business Development - Remote

Olympus Corporation of the Americas

Westborough, MA, US, 01581, United StatesRemotefull_timeVerifiedPosted 14 Dec 2023

💰 $181,166/yr($129,404/yr – $181,166/yr)

About the role

Working Location: MASSACHUSETTS, WESTBOROUGH

Workplace Flexibility: Hybrid

Are you looking for a company that cares about people’s lives and health, including yours? Let’s inspire healthier lives, together.

Olympus, a leading medical technology company, has focused on making people’s lives better for over 100 years.

Our Purpose is to make people’s lives healthier, safer, and more fulfilling.

Our Core Values are reflected in all we do: Integrity – Empathy – Agility – Unity – Long-Term View

We deliver on our purpose and our core values by staying True to Life.

Job Description

The Senior Business Development Regulatory Affairs Manager will report to the Business Development RA Director and is responsible to help drive strategic and tactical functional support for business development projects. This important role will be a key partner to the global Business Development core-team to ensure the RA function’s perspective, expertise, critical-thinking is embedded throughout an acquisition and integration efforts.

Job Duties

Support Business Development projects as the global RA representative between RA functional teams, BD core-team, and cross-functional partners;
Responsible for supporting and researching in-depth analysis of Medical Device and other relevant regulations as it pertains to the business development project;
Understand and provide insight of a potential acquiring company’s (Target) product portfolio, regulatory compliance risks/violations, global market footprint, etc.;
Drive initial drafts of a global regulatory plan that aligns with the BD Commercial team’s priorities;
Collaborate with BD cross-functional leads to provide regulatory insight and/or complete any deliverables;
Assess current capabilities, systems, policies, processes, organizational structure, and resources for conducting RA due diligence, integration strategy/planning activities, and integration execution against best practices;
Provide recommendations to BD core-team and/or BD RA Director regarding all deliverables and required milestones;
Support the Tool & Process Development and Continuous Improvement project by creating or improving RA tools, standard operating processes, playbooks, and lessons learned documentations;
Help develop a clear integration plan, agreed to by BD, BD RA Director and applicable RA senior leaders;
Understand resource planning and intercompany RA skills / expertise to drive resource recommendations;
Help maintain an up-to-date view of all projects in the business development pipeline to be communicated to RA senior leaders;
Coordinate with global and regional regulatory teams as applicable;
Identify regulatory issues, concerns, watchouts associated with a Target’s regulatory technical documentation and licenses;
Build and maintain a network of resources in all regions, across all businesses and divisions;
Support efforts for RA functional and regional alignment;
Help to on-board RA Integration leader to ensure smooth transition post deal close and into first 100 days of integration activities;
Other BD project related tasks and deliverables as determined by the BD core-team and/or BD RA Director.

Job Requirements

Required:

Bachelor’s degree required.
Minimum 10 years’ experience in regulatory affairs and medical device industry
Strong USA FDA and EU MDR regulatory knowledge and/or submission experience
Familiar with clinical requirements to support global, regulatory approvals
Understanding of DMR, DHR, and DHF and the required documentation
Strong excel, PPT and Smartsheet skills
Excellent written and oral communication skills
Ability to present clear messaging across all levels of an organization, including senior leadership

Why join Olympus?

Here, people matter—our health, our happiness, and our lives.